Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov Triclopyr Interim Registration Review Decision Case Number 2710 December 2020 JL- Approved by: Mary Elissa Reaves, Ph.D. Acting Director Pesticide Re-evaluation Division Date: 12-16-2020 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov Table of Contents I. INTRODUCTION 3 A. Updates since the Proposed Interim Registration Review Decision was Issued 4 B. Summary of Triclopyr Registration Review 4 C. Public Comments on the Proposed Interim Registration Review Decision and Agency Responses 6 II. USE AND US AGE 14 III. SCIENTIFIC ASSESSMENTS 15 A. Human Health Risks 15 B. Ecological Risks 19 C. Benefits Assessment 26 IV. INTERIM REGISTRATION REVIEW DECISION 27 A. Risk Mitigation and Regulatory Rationale 27 B. Tolerance Actions 37 C. Interim Registration Review Decision 38 D. Data Requirements 38 V. NEXT STEPS AND TIMELINE 39 A. Interim Registration Review Decision 39 B. Implementation of Mitigation Measures 39 Appendix B: Summary of Risk Mitigation for Triclopyr 42 Appendix C: Labeling Changes for Triclopyr Products 43 Appendix D: Endangered Species Assessment 50 Appendix E: Endocrine Disruptor Screening Program 51 2 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov I. INTRODUCTION This document is the Environmental Protection Agency's (the EPA or the Agency) Interim Registration Review Decision (ID) for triclopyr and is being issued pursuant to 40 CFR § 155.56 and § 155.58. The triclopyr registration review case encompasses the following forms of the active ingredient: triclopyr acid (acid, PC code 116001), triclopyr choline salt (COLN, PC code 116000), triclopyr butoxyethyl ester (BEE, PC code 116004), and triclopyr triethylamine salt (TEA, PC code 116002). A registration review decision is the Agency's determination whether a pesticide continues to meet, or does not meet, the standard for registration in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The Agency may issue, when it determines it to be appropriate, an interim registration review decision before completing a registration review. Among other things, the interim registration review decision may determine that new risk mitigation measures are necessary, lay out interim risk mitigation measures, identify data or information necessary to complete the review, and include schedules for submitting the necessary data, conducting the new risk assessment and completing the registration review. Additional information on triclopyr, can be found in the EPA's public docket (EPA-HQ-OPP-2014-0576) at www.regulations.gov. FIFRA, as amended by the Food Quality Protection Act (FQPA) of 1996, mandates the continuous review of existing pesticides. All pesticides distributed or sold in the United States must be registered by the EPA based on scientific data showing that they will not cause unreasonable risks to human health or to the environment when used as directed on product labeling. The registration review program is intended to make sure that, as the ability to assess and reduce risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no unreasonable adverse effects. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review program, the Agency periodically re-evaluates pesticides to make sure that as these changes occur, products in the marketplace can continue to be used safely. Information on this program is provided at http://www.epa.gov/pesticide-reevaluation. In 2006, the Agency implemented the registration review program pursuant to FIFRA § 3(g) and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration. The EPA is issuing an ID for triclopyr so that it can (1) move forward with aspects of the registration review that are complete and (2) implement interim risk mitigation (see Appendices B and C). The Agency is currently working with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (collectively referred to as, "the Services") to develop methodologies for conducting national threatened and endangered (listed) species assessments for pesticides in accordance with the Endangered Species Act (ESA) § 7. Therefore, although the EPA has not yet fully evaluated risks to federally-listed species, the Agency will complete its listed species assessment and any necessary consultation with the Services for triclopyr prior to completing the triclopyr registration review. Likewise, the Agency will complete endocrine screening for triclopyr, pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA) § 408(p), before completing registration review. See Appendices D and E, respectively, for additional information on the listed species assessment and the endocrine screening for the triclopyr registration review. 3 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov Triclopyr is a pyridine carboxylic acid herbicide with selective toxicity to broadleaf weeds and some woody plants. It is classified as a group 4 herbicide according to the Weed Science Society of America and like other herbicides in this group, its mode of action is as a synthetic auxin (mimicking natural plant hormones). Products containing triclopyr are registered for use on rice, orchards, rangeland and pasture, forests, rights of way, commercial turf including golf courses, sod farms, residential/institutional turf, and aquatic sites (lakes, ponds, rivers, marshes, and wetlands). The first pesticide products containing triclopyr were registered in 1979. The Reregi strati on Eligibility Decision (RED) for triclopyr was published in 1998. This document is organized in five sections: Introduction, which includes this summary and a summary of public comments and the EPA's responses; Use and Usage, which describes how and why triclopyr is used and summarizes data on its use; Scientific Assessments, which summarizes the EPA's risk and benefits assessments, updates or revisions to previous risk assessments, and provides broader context with a discussion of risk characterization; Interim Registration Review Decision, which describes the mitigation measures necessary to address risks of concern and the regulatory rationale for the EPA's ID; and, lastly, Next Steps and Timeline for completion of this registration review. A. Updates since the Proposed Interim Registration Review Decision was Issued In the Proposed Interim Registration Review Decision (PID) for triclopyr, EPA proposed mitigation to prevent non-target plant damage by prohibiting triclopyr-treated materials from being used for compost, mulch, or mushroom spawn for 30 days after application. EPA is updating this language to focus on prohibiting these materials from being moved offsite for use in compost or as animal feed or bedding until 30 days after application. The triclopyr PID also proposed label language that prevented animals that had grazed on treated plant material from being moved from the treated property until they were fed forage free of triclopyr for 3 days. EPA is updating this language to note that animals that have grazed on treated plant material cannot be moved to areas where manure may be collected, or sensitive crops are grown until they are fed forage free of triclopyr for 3 days. This compost prohibition and animal clean out language will also only be needed on products registered for applications to either turf or pastures. These updates to the compost risk mitigation will allow for greater flexibility for property and livestock owners while helping to prevent treated materials or manure with triclopyr residues from entering the compost stream. In addition, minor updates to the spray drift labeling are included in this ID. EPA has also reviewed an acute larval honey bee study (MRID 51068101), which was an outstanding data need identified in the PID, and has found the study acceptable and the guideline satisfied. B. Summary of Triclopyr Registration Review Pursuant to 40 CFR § 155.50, the EPA formally initiated registration review for triclopyr with the opening of the registration review docket for the case. The following summary highlights the docket opening and other significant milestones that have occurred thus far during the registration review of triclopyr. 4 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov • December 2014 - The Triclopyr Preliminary Work Plan (PWP), the Triclopyr; Triclopyr Triethylamine Salt (TEA); and Triclopyr Butoxyethyl Ester (BEE) Human Health Assessment Scoping Document in Support of Registration Review, and the Registration Review: Preliminary Problem Formulation for Environmental Fate and Ecological Risk, Endangered Species and Drinking Water Assessments for Triclopyr were posted to the docket for a 60-day public comment period. • June 2015 - The Triclopyr Final Work Plan (FWP) was issued. Comments were received from the FIFRA Endangered Species Task Force, Corteva Agriscience (formerly Dow AgroSciences), the San Francisco Bay Regional Water Quality Control Board, and the California Stormwater Quality Association, but comments did not alter the registration review timeline or anticipated risk assessments. Four studies not included in the PWP were added to the list of required studies in the FWP: field testing for pollinators (guideline 850.3040), field trial of residues in pollen and nectar (non-guideline), aerobic soil metabolism (guideline 835.4100), and aerobic aquatic metabolism (guideline 835.4300). • March 2016 - A Generic Data Call-In (GDCI 116001-1546) for triclopyr was issued for data needed to conduct the registration review risk assessments. The avian acute oral toxicity study with passerine bird (MRID 50294201) was submitted and is in review. • November 2019 - The Agency announced the availability of the Triclopyr, Triclopyr Butoxyethyl Ester, and Triclopyr Salts Human Health Draft Risk Assessment to Support Registration Review and the Triclopyr (Acid, Choline salt, TEA salt, BEE): Draft Ecological Risk Assessment for Registration Review for a 60-day public comment period. There were four comments from four different sources received on the risk assessments. These comments did not change the risk assessment conclusions or registration review timeline for triclopyr. • September 2020 - The Agency announced the availability of the PID for triclopyr in the docket for a 60-day public comment period, which opened on September 2, 2020 and closed on November 2, 2020. Along with the PID, the following documents were posted to the triclopyr docket: o Triclopyr: Response to Comments on the Draft Risk Assessment to Support Registration Review, dated June 9, 2020. o Usage, Benefits and Impact Assessment for Triclopyr, dated June 11, 2020. o Aggregate Risk Assessment for Trichloropyridinol (TCP) Metabolite of Triclopyr (PC 116001), Chlorpyrifos (PC 059101), and Chlorpyrifos-methyl (PC 059102), dated June 6, 2002. • December 2020 - The Agency has completed the triclopyr ID and will post it in the triclopyr registration review docket (EPA-HQ-OPP-2014-0576). 5 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov C. Public Comments on the Proposed Interim Registration Review Decision and Agency Responses During the 60-day public comment period for the triclopyr PID, which opened on September 2, 2020 and closed on November 2, 2020, the Agency received 8 public comments. An additional comment from the San Francisco Bay Water Quality Control Board pertaining to another case was mistakenly posted in the triclopyr docket. Comments were received from Corteva Agriscience, the triclopyr technical registrant, the United States Department of Agriculture (USDA), the City of Sacramento Department of Utilities, National Agricultural Aviation Association, the National Association of Landscape Professionals, Trugreen, and the Scotts Company, LLC. The public comments are summarized below, along with the Agency's responses. The Agency thanks all commenters and has considered all comments in the development of this ID. Comment Submitted by Corteva Agriscience (EPA-HQ-OPP-2014-0576-0056) Comment: Corteva argued that there is insufficient evidence of compost contamination to justify compost mitigation for triclopyr products. They stated that livestock and material holding times will place burdens on landowners and livestock managers. Corteva proposed that EPA refrain from requiring compost mitigation until data on triclopyr's persistence in compost is available. Corteva also stated that the primary agricultural uses for triclopyr are for non-pollinator sites such as rice, aquatic weeds, and non-cropland sites which presents a lower likelihood of exposure to pollinators. Corteva also notes that other use sites such as pasture/rangeland, forestry, and rights-of-ways may contain flowering plants but application of triclopyr will likely cause the death of the targeted plant. EPA Response: EPA appreciates Corteva's comment on the proposed triclopyr mitigation. There is limited data on how long triclopyr persists in compost and there have been few reported incidents of compost contamination involving triclopyr alone. USDA noted in its comments that experts reported one or two cases involving homeowners that clipped turfgrass that had been treated a day or two prior, and when green clippings were used as mulch, there was damage to tomato plants.1 There is one incident reported of non-target plant damage from compost involving a mixed triclopyr and clopyralid product. However, the low number of incidents does not necessarily indicate that there is no potential for compost contamination. While there have not been any compost contamination incidents reported associated with triclopyr alone, based on triclopyr's fate properties, its toxicity to non-target terrestrial plants, and its structural similarity to herbicides with known compost issues, the Agency continues to be concerned with triclopyr's potential to contaminate compost. Due to these reasons, additional data are needed to better understand triclopyr's potential to contaminate compost, these data are: • A modified guideline 835.6100 terrestrial field dissipation study with a duration of at least 30 days 1 See USDA's Ml comments at: https://www.regulations.gov/document?D=EPA-HQ-OPP-2014-0576-0059 6 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov • A non-guideline compost kinetics study for vegetative material and manure • A non-guideline compost bioassay study for both vegetative material and manure For other synthetic auxin herbicides such as aminocyclopyrachlor, aminopyralid, clopyralid, and picloram with reported compost incidents, EPA has considered a broad suite of mitigation measures to address the concerns with compost contamination. Taking the chemical-specific considerations into account and using a proportional mitigation approach, EPA has determined that a statement instructing users not to use treated plant materials (e.g., hay, turf clippings) or manure from animals that have grazed in treated areas for offsite composting or offsite animal feed/bedding until 30 days after application is necessary. In addition, the Agency has determined that a 3-day clean out period for livestock that have grazed on treated plant materials and are being moved to areas where manure can be collected or where sensitive crops are grown is necessary to address potential composting concerns for triclopyr. The updated compost restrictions should provide more flexibility for stakeholders and add less burden for applicators, while targeting use sites that are the most likely pathways for compost contamination. The Agency will review the need for compost labeling in future decisions, considering any new compost data available. While some uses for triclopyr are on sites with little pollinator attractiveness, like rice, there is potential exposure from pasture/rangeland, forestry, turf with blooming flowers, and rights-of- ways uses as Corteva has noted. Corteva is correct that flowers exposed to triclopyr will likely die eventually after application which would limit the window of time for pollinator exposure. While EPA has not determined that mandatory pollinator specific mitigation is necessary for triclopyr, mandatory spray drift language and non-target organism advisory statements are necessary to mitigate potential risks to terrestrial invertebrates that may forage or live on non- target plants near treated areas. Given the chronic risk concerns identified to adult and larval honeybees, additional Tier II honeybee data are needed to better assess the risks of the use of triclopyr acid. Specifically, a Tier II semi field test for pollinators (tunnel or colony feeding) and Tier II field trial of residues in pollen and nectar study are needed. These higher-tier data will help to refine the understanding of potential exposure to bees from the registered uses of triclopyr, and the extent of risk at the colony level. Data on the magnitude and persistence of triclopyr BEE in pollen and nectar is also needed to refine the understanding of potential exposure of bees from the registered uses of triclopyr BEE. Comment Submitted by USDA (EPA-HQ-OPP-2014-0576-0059) Comment: USDA noted general benefits for use of triclopyr in pasture, rangeland, forest, orchard, non-crop settings, turfgrass, and rice. USDA stated that in pasture and rangeland, triclopyr can be applied as a broadcast application to control larger patches of herbaceous weeds, but these broadcast applications are limited. More broadly, triclopyr has targeted applications to control isolated brush or trees or as basal bark or cut-stump treatments. Targeted spot treatments have been important in orchards where applicators need to protect sensitive crops nearby. USDA noted that compared to alternatives, triclopyr has equivalent or greater efficacy against target weeds, provides greater safety for non-target vegetation, and offers greater flexibility with a 7 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov wider range of application methods. Triclopyr has effectively controlled invasive trees without injuring surrounding vegetation. In turfgrass use sites, USDA noted that triclopyr is applied as a broadcast application as part of a tank mix with other herbicides or alone as a targeted application to manage difficult broadleaf weeds. USDA stated that according to its outreach to weed scientists, triclopyr has essentially replaced clopyralid as the recommended pyridine herbicide for turfgrass for control of weeds resistant to other herbicides. Triclopyr offered benefits for use in rice because rice is sensitive to phenoxy herbicide alternatives (2,4-D and MCPA) and has been a critical component of an integrated weed resistance management program. USDA argued that due to triclopyr products being typically used for spot applications it is not valid to scale up these applications as wide- area broadcast applications at very high rates. USDA stated that much of the risks identified in the ecological risk assessment are driven by modeled rates of 6 and 9 lbs a.e./A. USDA was generally supportive of proposed mitigations in the triclopyr PID that address personal protective equipment (PPE), spray drift mitigation, environmental hazards, and herbicide resistance management. USDA suggested that the Agency tailor the spray drift mitigation to the specific use sites. For example, triclopyr applications to turf in residential settings were made with equipment with nozzles that are only inches away from the top of the turf canopy or with coarse to very coarse droplets. USDA argued that the proposed spray drift mitigation would not be practical for products labeled for use exclusively in turfgrass. USDA also suggested a minor editorial change for the droplet size requirement, to note that applicators are required to select nozzles and pressure that deliver medium or coarser droplets as indicated in manufacturers' catalogues and in accordance with ASABE S572. USDA is concerned about the proposed compost mitigation as there are few recorded compost incidents involving triclopyr. USDA noted that labeled uses, aside from of turfgrass and pastures, have a very small likelihood of treated materials ending up in the compost waste stream. USDA agreed there are uncertainties remaining on the potential for triclopyr residues to end up in compost or manure. USDA argued that based on the data and literature available, there is evidence of low potential for persistence in treated materials, especially when compared to other pyridine herbicides like clopyralid. USDA cited data from various open literature studies conducted in woody plants measuring the persistence of triclopyr in treated plant materials but notes there are no published studies on the persistence of triclopyr residues in turfgrass. There are few studies that have looked at the persistence of triclopyr in compost or manure. USDA found data from the Australian government2, which studied the persistence of picloram, clopyralid, and triclopyr residues in compost after 16 weeks of composting under commercial conditions. The study found that triclopyr residues degraded at exponential rates compared to picloram and clopyralid. USDA urged EPA to mitigate compost risk proportionally compared to other pyridine herbicides. USDA suggested that EPA instead use label language that would prohibit residential turf clippings for mulching around fruit trees or vegetables, environmental hazard language detailing potential composting risks, and developing educational materials and best management practices for turfgrass and pasture grass. USDA offered to facilitate the formation of a working 2 New South Wales Department of Environment and Conservation. 2004. Persistent Herbicides Risk Management Program. Available at: https://www.epa.nsw.gov.au/resources/warrlocal/050365-herbicides.pdf 8 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov group to resolve uncertainties regarding persistent herbicides and their impact on organic waste products. USD A did not think that the majority of triclopyr uses will result in exposure to pollinators as it is either applied to non-pollinator attractive crops or applied to the basal bark or stump. They contended that pasture and rangeland are the most realistic uses that could expose pollinators to triclopyr and suggests that the environmental hazard language for pollinators could be applied to just these uses. USDA suggested that EPA work closely with the registrant to ensure that the Tier II testing is designed to likely capture realistic exposure scenarios based on triclopyr use sites likely to be attractive to pollinators. EPA Response: The Agency appreciates the information provided by USDA concerning the benefits of triclopyr as well as additional stakeholder feedback on the compost issue. EPA acknowledges that there is not enough information on the persistence of triclopyr residues in turfgrass. EPA's review of the open literature indicates that triclopyr residues were observed in plant materials that may be used for mulch and/or composting.3'4 The level of triclopyr residues found, following application, depends on factors such as application rate, the type of plant foliage, and environmental factors. The persistence of triclopyr residues in plant tissues appears to be dependent on the type of plant.5 And in animals feeding on triclopyr-contaminated feed, triclopyr was excreted mainly in urine and not in feces.6 EPA did a cursory review of the Australian government study cited by USDA, and while the study does show that triclopyr degrades quickly compared to picloram and clopyralid, residues in compost would still be a concern because even after 6 weeks, there was still about a third of triclopyr's initial concentration remaining. In its comments, USDA noted the lack of compost incidents for triclopyr, but noted later in its comments that "experts did report one or two cases involving homeowners that clipped turfgrass that had been treated a day or two prior... and when the green clippings were used as a green mulch on tomatoes, the turf clippings resulted in damage to the tomato plant." These incidents were not reported to EPA, and this is the first that the Agency has received news of any compost incidents associated with triclopyr-treated residential grass clippings. However, this confirms EPA's concerns that users may not know how to report incidents to the Agency, and even when incidents are reported, the source of phytotoxicity is difficult to determine without residue testing, which can be expensive. The low frequency of reported compost incidents is not evidence that compost contamination is not of concern for triclopyr. Newton M. et al 1990. Deposition and Dissipation of Three Herbicides in Foliage, Litter, and Soil of Brush fields of Southwest Oregon. J. Agric. Food Chem. 1990, 38, 574-583. Available at: https://pubs.acs.org/doi/pdf/10.1021/if00Q92a052 4 Wenxi Li. et al 2018. Residue determination of triclopyr and aminopyralid in pastures and soil by gas chromatography-electron capture detector: Dissipation pattern under open field conditions. Ecotoxicity and environmental safety volume 155, 15 My 2018, Pages 17-25 Available at: https://www.sciencedirect.eom/science/article/abs/pii/S0.l.476513183012107via%3Dihnb 5 Norris, L. et al 1987. Triclopyr Persistence in Western Oregon Hill Pastures. Environmental Bulletin of Environmental Toxicology (1987) 39:134-141. Available at: https://link.springer.com/article/10.1007/BF01691801 6 Eckerlin, R.H et al 1987. Excretion of triclopyr herbicide in the bovine. Bulletin of Environmental Toxicology (1987) 39:443-447. Available at: https://link.springer.com/article/10.1007/BF016883Q8 9 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov For other synthetic auxin herbicides such as aminocyclopyrachlor, aminopyralid, clopyralid, and picloram with reported compost incidents, EPA has considered a broad suite of mitigation measures to address the concerns with compost contamination. The Agency is requiring compost labeling for persistent herbicides based on a weight of evidence approach. Based on triclopyr's fate properties, its toxicity to non-target terrestrial plants, its structural similarity to herbicides with known compost issues, and information from comments submitted by USDA noting a couple compost incidents associated with residential turf clippings, the Agency continues to be concerned with triclopyr's potential to contaminate compost. Taking the chemical-specific considerations into account and to continue to use a proportional mitigation approach, as USDA suggested, EPA is updating the compost prohibition to focus on preventing offsite transportation of treated plant materials and manure for composting and animal feed/bedding uses for 30 days after application. The Agency is also changing the animal clean out period language to clarify that animals should not be moved to areas where manure can be collected or where sensitive crops are grown until they have been fed forage free of triclopyr for 3 days. The compost mitigation language will also only be required on products with pasture and turf use sites, since these sites are thought to have the highest risks for materials entering the compost stream. These updates to the compost restrictions should provide more flexibility for stakeholders and add less burden for applicators, while targeting use sites that are the most likely pathways for compost contamination. In the triclopyr PID, the spray drift labeling within the document was not consistent between Section IV of the document and the label table. In this ID, EPA has corrected those differences as USDA suggested, and is also making changes to the references to the AS ABE standard for aerial application equipment. While USDA suggested altering the spray drift requirements based on certain application sites, such as turfgrass, EPA's spray drift labeling is associated with certain application equipment (i.e., ground boom and aerial application equipment) and not a particular use site. No exceptions for certain crops or uses have been added in this ID. As described in EPA's response to the Corteva pollinator comments above, mandatory spray drift language and non-target organism advisory statements are necessary to mitigate potential risks to terrestrial invertebrates that may forage or live on non-target plants near treated areas. Given the chronic risk concerns identified to adult and larval honeybees, additional Tier II honeybee data are needed for triclopyr acid. USDA stated applications of triclopyr are often spot treatments and the high rates, up to 6 to 9 lbs ae/A, included in EPA's ecological risk assessment may not reflect the actual use of these products. EPA's ecological risk assessment calculated potential triclopyr risk using the maximum allowed rates on triclopyr labels. However, the triclopyr PID also included additional information provided by USDA on more typical triclopyr use rates, leading EPA to conclude that risks to non-target organisms from use on forests, non-crop areas, and rights of ways are likely lower than estimated in the ecological risk assessment. 10 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov Comment Submitted by Sacramento River Source Water Protection Program (SRSWPP) (EPA-HQ-OPP-2014-0576-0054) Comment: SRSWPP expressed concern regarding the potential for triclopyr, and its metabolite trichloropyridinol (TCP), to affect drinking water quality. There was concern that surface water modeling in the Agency's drinking water assessment fails to incorporate estimates of exposure from the metabolite TCP. SRSWPP also argued that the 2002 TCP aggregate risk assessment uses methods and assumptions that are outdated and should not be relied upon for assessment of drinking water exposure from triclopyr and TCP. Although Estimated Drinking Water Concentrations (EDWCs) were calculated, there is remaining concern as these values were not compared to environmental reference values, such as Human Health Benchmarks for Pesticides (HHBPs). For surface water, the chronic EDWC produced by EPA's modeling exceeds EPA's chronic HHBP. SRSWPP cited water monitoring data to support their concern regarding exposure to TCP via drinking water consumption. SRSWPP noted that the proposed spray drift mitigation may help to reduce potential surface water contamination via drift, but additional mitigation may be needed to reduce triclopyr transport into water supplies. They suggest that the surface water advisory for agricultural products be replaced by a mandatory requirement for vegetative buffer strips between agricultural land where triclopyr is applied and surface water, that products should not be applied within 48 hours of expected rainfall or irrigation, and that labels specify that products should not cause triclopyr concentrations to exceed a chronic HHBP of 300 ppb. SRSWPP also asked that EPA evaluate effects of the metabolites, degradates, and transformation products formed during and subsequent to the water treatment process, assess cumulative effects of pesticides and their breakdown products in drinking water, and require water quality monitoring and data collection by registrants to support these evaluations. EPA Response: The Agency thanks SRSWPP for their comment on the triclopyr PID. HHBPs are screening-level values for informational use by public utilities, and the approach for deriving HHBPs differ from EPA's methodology for assessing pesticidal exposures and risks under the FIFRA and the FFDCA. The HHBP is used to determine a level of pesticide concentration that may indicate a potential health risk assuming a default relative drinking water source contribution of 20 percent and are not legally-enforceable standards. As noted in the triclopyr human health risk assessment, the dietary (food and water) and aggregate exposures are well below the level of concern. Regarding potential cumulative effects, EPA has not made a common mechanism of toxicity finding as to triclopyr and any other substances, but has noted that an environmental degradate of triclopyr, TCP, may also be an environmental degradate of other registered pesticides. While TCP is derived from multiple chemicals, the conclusions of the 2002 TCP risk assessment demonstrate that the aggregate dietary exposure to TCP is not a risk of concern, as the total usage for all the compounds (that generate TCP) is lower now than 2002. NHANES biomonitoring studies show that levels of the metabolite TCP has reduced considerably from 2000-2010, further indicating that there is less exposure to TCP.7 For the purposes of this action, therefore, EPA has not assumed that triclopyr has a common mechanism of toxicity with other substances. Given 7 https://www.cdc.gov/nchs/nhanes/index.htm 11 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov that no dietary or aggregate risks of concern were identified for triclopyr, the Agency determined that no additional mitigation is necessary to address drinking water exposures. Comment Submitted by National Agricultural Aviation Association (NAAA) (EPA-HQ- OPP-2014-0576-0055) Comment: NAAA stated the overall importance of aerial applications and the advantages of aerial applications over other forms of application. While NAAA supports the proposed spray drift mitigation language for aerial applications, NAAA described the need for clear label language regarding the specific altitude above which temperature inversions are not of concern. NAAA states it is currently collaborating with the USDA-ARS Aerial Application Technology Research Unit to conduct a literature review on the matter. NAAA does not find the PF-10 respirator requirement for mixing and loading for aerial forestry use to be overly burdensome but is concerned that the estimated risks that lead to this requirement may be based largely on the greater number of acres treated daily by aerial application compared to the other application methods. NAAA argues that if PPE is used properly, mixing and loading for more acres should not automatically be assumed to increase the exposure to a mixer/loader. EPA Response: EPA thanks NAAA for the comments and for its work with USDA-ARS to conduct a literature review. The Agency will review any additional information submitted regarding the altitude of temperature inversions as it relates to pesticide applications. The Agency will also consider revisions to the label language if supported by the information submitted. EPA's occupational risk assessment does consider the number of acres typically treated in a day in the calculation of occupational handler risk. This assumes the longer someone is doing a particular task, the more potential exposure they may receive in a given time period. While PPE, like respirators, do help reduce exposure, they do not eliminate it completely. Aerial forestry applications were assessed using a lower acreage assumption of 1,200 (where the default is 7,500 acres). At this lower acreage assumption, risks of concern for mixers/loaders for aerial forestry applications were still identified due to the use of a 10X database uncertainty factor for lack of a guideline 870.3465 subchronic inhalation toxicity study. At the request of the registrant, Corteva Agriscience, EPA agreed to waive the requirement for the subchronic inhalation toxicity study if a respirator was added to labels for mixers/loaders for the aerial forestry scenario. Comment Submitted by National Association of Landscape Professionals (NALP) (EPA- HQ-OPP-2014-0576-0053) Comment: The National Association of Landscape Professionals state the importance of triclopyr to the lawn care and landscaping business. NALP states that turf uses of triclopyr are unlikely to result in exposure to pollinators since the application of triclopyr to turf is intended to keep blooming weeds from proliferating. NALP also notes that there have been no compost contamination incidents for triclopyr products and that professional landscapers do not use grass clippings as mulch. Due to EPA's concerns for pollinators and compost contamination, NALP 12 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov sees the need for the development and adoption of best management practices for triclopyr use (or even pyridines generally) in lawn and landscape settings to educate applicators on these issues. EPA Response: EPA thanks NALP for their comments on the triclopyr PID. Similar comments related to pollinators were received from Corteva and EPA's response is provided above. While EPA is not requiring a registrant-generated stewardship plan for triclopyr, the Agency agrees that the education of applicators and land managers on turf best management practices for the pyridine herbicides as a group is important. Education and stewardship efforts are being initiated for other pyridine herbicides with compost contamination concerns. As additional education or stewardship materials related to compost concerns are made available, EPA will continue to encourage the distribution of those resources to other stakeholders. Comment Submitted by Trugreen (EPA-HQ-OPP-2014-0576-0057) Comment: Trugreen stresses the importance of triclopyr to the lawn and landscape industries. Trugreen is concerned about the proposed compost mitigation and does not believe that compost mitigation is warranted for triclopyr until EPA has fully considered all available science, investigated any incident claims, and evaluated impacts of the mitigation. Trugreen states that while triclopyr may be present in plant material for 30 days after application, its persistence in plant tissue alone cannot determine the impact on treated grass clippings used as compost. It is more important to understand how triclopyr can release from clippings and be absorbed by non- target plants at concentrations high enough to produce phytotoxicity. Trugreen also noted it was not aware of any compost related incidents in its 30-year history of using triclopyr. EPA Response: EPA thanks Trugreen for the comments on the triclopyr PID. As mentioned in responses to similar compost mitigation comments from USDA and the registrant, Corteva, the lack of incidents is not evidence that incidents are not occurring. Compost incidents may not be reported, and even when reported, it is difficult to verify the source of phytotoxicity without laboratory testing, which can be expensive. The Agency agrees it is important to understand how triclopyr can release from grass clipping and be absorbed by non-target plants, which is why additional compost studies are being required for triclopyr. Until adequate compost data are available, EPA is using a weight of evidence approach to determine if compost labeling is needed for certain persistent herbicides. Based on its fate properties, its toxicity to non-target plants, and its structural similarity to pesticides with known compost issues, EPA continues to have concerns with potential compost contamination for certain triclopyr uses, such as pasture and residential turf. The Agency has determined that label statements noting that treated plant materials and manure from animals that have grazed on treated sites should not be transported offsite for recycling into compost for 30 days after application are necessary to help inform land managers of the potential for down-stream phytotoxicity. The Agency has also determined that a 3-day grazing animal clean-out period is necessary for triclopyr. 13 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov Comment Submitted by the Scotts Company, LLC (EPA-HQ-OPP-2014-0576-0051) Comment: The Scotts Company sought clarification on the necessary labeling for residential consumer products. They also suggested that, for consumer products, if the registrant reviews the Label Review Manual and determines that gloves are applicable, then "waterproof gloves" should be added. The Scott's Company noted that the mode of action and other resistance management information is not applicable to residential consumer products. EPA Response: The Agency agrees with the Scotts Company that mode of action information and other resistance management labeling is not necessary for residential consumer products. The Agency appreciates the information provided and has added clarification to the Appendix B label table. The appropriate glove material is dependent on the individual product formulation and the acute dermal exposure toxicity profile of each individual formulation. EPA is not changing the updated glove statement language as waterproof gloves may not be appropriate for every product and urges each registrant to choose the appropriate glove type(s) to list on their label based on the current guidance in the Label Review Manual. II. USE AND USAGE Triclopyr is a group 4 systemic herbicide according to the Weed Science Society of America's site of action group number. It acts as a synthetic auxin and causes uncontrolled cell division and growth resulting in vascular tissue destruction at low concentrations and inhibits cell division and growth at higher concentrations. It is in the pyridine carboxylic acid family and is used to control broadleaf weed species and woody plants and vines postemergence in agricultural use sites in rice, citrus in Florida, orchards in California, pasture and rangeland, and non- agricultural use sites including forestry, rights of ways, sod farms, commercial/institutional turf, and residential lawns. It is also used to control aquatic weeds growing in lakes, ponds, reservoirs, and wetlands, and to control woody brush and herbaceous weeds in wetlands and on the banks and shores of aquatic sites. Triclopyr products are formulated as soluble concentrates, emulsifiable concentrates, liquids, granules, wettable powders, and pellets. For granular formulations, granules are broadcasted onto turf in wet conditions and onto aquatic weeds present on the water surface and those present in the subsurface. For liquid formulations and water dispersible granules, a tank mix is prepared with an agriculturally labeled non-ionic surfactant and/or other herbicide, and the liquid is sprayed onto the target plants or aquatic weeds. Triclopyr can be applied as a broadcast application, or as a non-broadcast application such as cut stump and basal bark treatments, hack and squirt treatment, and girdle treatment. The broadcast applications may be applied using ground (backpack or truck-mounted pressure sprayers) or aerial equipment. Broadcast applications are used for control of weeds (terrestrial and aquatic) and woody plants in registered use sites by uniform spray targeting plant foliage. Ground equipment is typically used for spraying individual brush plants, woody plants and vines or spot treatment of weeds. The non- broadcast methods listed above are used to target undesirable woody plants in highly localized treatments. 14 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov The primary agricultural use sites for triclopyr are pastureland and rice. Approximately 1.1 million pounds of triclopyr are applied to 2.3 million acres per year, according to agricultural usage data. Pasture and rangeland accounts for approximately 1 million pounds applied on 1.8 million acres, which is an estimated 90% of all pounds of triclopyr applied annually and 80% of all acres treated with triclopyr annually. The second largest agricultural use site is rice, which accounts for about 10% of all pounds of triclopyr applied annually and 20% of all acres treated with triclopyr annually. Rice has the highest percent crop treated (PCT), at approximately 15%. For non-agricultural uses, triclopyr is applied in industrial vegetation management, recreational/commercial/industrial turf, golf courses, landscape ornamentals, ornamental nurseries and residential lawns. In 2016, 3.1 million pounds of triclopyr were applied in industrial vegetation management sites and over 40,000 pounds of triclopyr were applied to residential lawns by professional lawn care operators. In 2013, approximately 1.8 million pounds of triclopyr were applied on professional lawn and ornamental sites. For additional information on the usage of triclopyr, see the document Usage, Benefits and Alternatives for Triclopyr. III. SCIENTIFIC ASSESSMENTS A. Human Health Risks A summary of the Agency's human health risk assessment is presented below. The Agency used the most current science policies and risk assessment methodologies to prepare a risk assessment in support of the registration review of triclopyr. For additional details on the human health assessment for triclopyr, see the Triclopyr, Triclopyr Butoxyethyl Ester, and Triclopyr Salts. Human Health Draft Risk Assessment to Support Registration Review, which is available in the public docket. 1. Risk Summary and Characterization Dietary (Food + Water) Risks The Agency's dietary (food + water) risk assessment did not identify risks of concern. Acute dietary risk estimates were calculated but found not to be a concern; the highest exposed population subgroup is females between 13 to 49 years with risk estimates equal to 92% of the acute population-adjusted dose (aPAD), where risk estimates greater than 100% are of concern. Chronic dietary risk estimates were calculated but found to not be of concern. Children <1 years old were the highest-exposed population subgroup, with risk estimates equal to 46% of the chronic population-adjusted dose (cPAD), the Agency's level of concern for dietary risk is 100% of the PAD. Therefore, there are no dietary risks of concern for triclopyr. 15 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov Residential Handler Risks A residential handler dermal assessment was not conducted due to the lack of a dermal toxicity endpoint. Short-term inhalation exposures were assessed. The results of the residential handler exposure and risk assessment indicate that short-term inhalation risks are not of concern for all turf scenarios with margins of exposure (MOEs) ranging from 4,000 to 120,000 (where MOEs below the level of concern [LOC] of 1,000 are of concern). Residential Post-Application Risks A residential post-application dermal assessment was not conducted due to the lack of a dermal toxicity endpoint. Short-term oral and inhalation exposures were assessed. Short-term incidental oral post-application risk estimates for all turf scenarios are not of concern (i.e., MOEs > 100) with MOEs ranging from 220 to 98,000 (where MOEs below the LOC of 100 are of concern). Because triclopyr is applied directly to water for aquatic weed treatment, the Agency assessed post-application risks from swimming. Short-term inhalation post-application risk estimates for all swimmer scenarios are not of concern with MOEs ranging from 520,000 and 4,400,000 for children 3 to <6 years old and adults, respectively (where MOEs below the LOC of 1,000 are of concern). The post-application ingestion risk estimates for swimmers are also not of concern with MOEs ranging from 45,000 to 580,000 for children 3 to <6 years old and adults, respectively (where the LOC is 100). Aggregate Risks Aggregate risks reflect combined dietary (food and drinking water) and residential exposures. All aggregate risk estimates for triclopyr are not of concern. Non-occupational Spray Drift Non-occupational spray drift risk estimates reflect exposures for children and adults who have contact with turf where residues are assumed to be deposited via spray drift. A quantitative spray drift assessment for triclopyr was not required because the maximum application rate to a crop/target site multiplied by the adjustment factor for drift is less than the maximum direct spray residential turf application rate for any triclopyr products. Turf residential post-application MOEs are considered protective of this scenario. Since there are no residential post-application risks of concern for turf, there are no non-occupational spray drift risks of concern. Cumulative Risks The EPA has not made a common mechanism of toxicity to humans finding as to triclopyr and any other substance. A 2002 risk assessment of trichloropyridinol (TCP), a metabolite derived from multiple chemicals including triclopyr, was conducted and the Agency found that the acute and chronic dietary aggregate exposure estimates are below the LOC and are not a risk of concern. Since the conclusions of the 2002 TCP assessment are still considered valid, the EPA 16 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov has not assumed that triclopyr has a common mechanism of toxicity with other substances for the registration review risk assessment. Occupational Handler Risks Occupational handlers are individuals who are involved in the pesticide application process (including mixers, loaders, and applicators). All handlers are assumed to wear baseline attire, which consists of long-sleeved shirt, long pants, and shoes plus socks. For most occupational handler scenarios, inhalation MOEs ranged from 1,200 to 180,000 and were not of concern (where MOEs below the LOC of 1,000 are of concern) with baseline clothing (no respiratory protection) for both the short- and intermediate-term exposure durations. For aerial forestry applications, the baseline MOE for mixer/loaders is 250 and is therefore a potential risk of concern (LOC= 1,000). With the addition of a protection factor 10 (PF-10) respirator, the MOE would be 2,500 which is not of concern. A dermal endpoint was not selected; therefore, a quantitative dermal assessment was not conducted for occupational handler exposures. Occupational Post-Application Risks Post-application exposure describes exposures that occur when individuals are present in an environment that has been previously treated with triclopyr and includes activities such as hand-weeding or hand-harvesting. A dermal endpoint was not selected; therefore, a quantitative occupational post-application dermal assessment was not conducted. A quantitative occupational post-application inhalation exposure assessment was not performed. Occupational handler inhalation exposure is likely to result in higher exposure than occupational post application inhalation exposure. Since occupational inhalation handler exposure is not of concern, it is expected that occupational post-application inhalation exposure is also not a risk of concern. Product specific restricted entry intervals (REIs) for uses under the Worker Protection Standard should be based on the appropriate technical and product-specific acute toxicity categories as described in the EPA's Label Review Manual8. 2. Human Incidents and Epidemiology The last triclopyr human incidents search was conducted in 2014. The 2014 search found 928 incidents involving triclopyr, but the vast majority of incidents were of low severity. An updated search for human incidents was conducted on June 19, 2019 for new incidents since the 2014 search. Both the Incident Data System (IDS) and NIOSH Sentinel Event Notification System for Occupational Risk (SENSOR)-Pesticides databases were searched. From January 1, 2014 to June 19, 2019, there were 47 triclopyr incidents involving a single active ingredient and 47 triclopyr incidents involving multiple active ingredients were reported to Main IDS and there were 600 triclopyr incidents reported to Aggregate IDS. The number of 8 https://www.epa.gov/pesticide-registration/label-review-manual 17 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov incidents reported to IDS has declined by 59% over the last 10 years, from 222 incidents reported in 2009 to 92 incidents reported in 2018. A query of SENSOR-Pesticides identified 74 cases involving triclopyr from 2011 to 2015, 15 of which involved a single active ingredient. A review of incidents in both IDS and SENSOR- Pesticides indicates that most incidents usually were of minor severity. Based on the decline in incidents reported to IDS and the decline in triclopyr incidents reported to both IDS and SENSOR-Pesticides, there does not appear to be a concern at this time. The Agricultural Health Study (AHS) is a federally-funded study that evaluates associations between pesticide exposures and cancer and other health outcomes and represents a collaborative effort between the US National Cancer Institute (NCI), National Institute of Environmental Health Sciences (NIEHS), Centers for Disease Control and Prevention's (CDC's) National Institute of Occupational Safety and Health (NIOSH), and the US EPA. Triclopyr is included in the AHS and two studies investigated triclopyr exposure and any association with wheeze and sleep apnea. There is insufficient epidemiological evidence at this time to conclude that a clear associative or causal relationship exists between triclopyr and the health outcomes of wheeze and sleep apnea assessed in the two AHS studies reported. The Agency will continue to monitor the incident information. Additional analyses will be conducted if ongoing human incident monitoring indicates a concern. 3. Tolerances Tolerances for triclopyr are established under 40 CFR §180.417. A number of tolerances need to be modified for consistency with current Organization for Economic Cooperation and Development (OECD) rounding practices and commodity definitions. The anticipated changes to the tolerances for triclopyr are noted in Table 1. The Agency intends to undertake these tolerance actions pursuant to its Federal Food, Drug Cosmetic Act (FFDCA) authority. Table 1: Summary of Anticipated Tolerance Actions for Triclopyr Commodity/ Correct Commodity Definition Established Tolerance (ppm) Anticipated Tolerance (ppm) Comments 180.417(a)(1) Egg 0.05 0.05 Fish, shellfish, crustacean — 3.5 Commodity definition revision. Corrected values to be consistent with OECD Rounding Class Practice. Fish, freshwater, finfish — 3 Fish 3.0 — Fish, shellfish, mollusc — 3.5 Shellfish 3.5 — Grass, forage, fodder and hay, group 17, forage -- 700 Grass, forage 700.0 — Grass, forage, fodder and hay, group 17, hay 200 Grass, hay 200.0 — Milk 0.01 0.01 Poultry, fat 0.1 0.1 18 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov Commodity/ Correct Commodity Definition Established Tolerance (ppm) Anticipated Tolerance (ppm) Comments Poultry, meat 0.1 0.1 Poultry, meat byproducts, except kidney 0.1 0.1 Rice, grain 0.3 0.3 180.417(a)(2) Cattle, fat 0.10 0.1 Corrected values to be consistent with OECD Rounding Class Practice. Cattle, meat 0.10 0.1 Cattle, meat byproducts, 0.50 0.5 Goat, fat 0.10 0.1 Goat, meat 0.10 0.1 Goat, meat byproducts 0.50 0.5 Hog, fat 0.10 0.1 Hog, meat 0.10 0.1 Hog, meat byproducts 0.50 0.5 Horse, fat 0.10 0.1 Horse, meat 0.10 0.1 Horse, meat byproducts 0.50 0.5 Sheep, fat 0.10 0.1 Sheep, meat 0.10 0.1 Sheep, meat byproducts 0.50 0.5 4. Human Health Data Needs A guideline 870.3465 90-day inhalation toxicity study was required as part of the triclopyr registration review GDCI (GDCI-116001-1546). Although this study has not been submitted, in conversations with the Agency (May 6, 2020), Corteva Agriscience, the technical registrant, notes that it intends to add a respirator on labels to protect mixers/loaders for aerial forestry application. When this change is applied on labels during registration review labeling implementation, the Agency will consider waiving the 90-day inhalation toxicity data requirement. A guideline 875.2100 chemical specific turf transferable residue (TTR) study was noted as a data gap in the scoping document and human health risk assessment. This TTR study has been submitted (MRID 45249601) and has been reviewed. The TTR study does not impact the current risk conclusions because the residential exposures are similar or lower than what was assessed in the human health risk assessment. In 2016, the Agency reevaluated the toxicological endpoints and determined no hazard was identified for the dermal exposure and therefore a quantitative dermal assessment is not needed. No additional human health data are required to support triclopyr registration review at this time. B. Ecological Risks A summary of the Agency's ecological risk assessment is presented below. The Agency used the most current science policies and risk assessment methodologies to prepare a risk assessment in support of the registration review of triclopyr. For additional details on the ecological assessment for triclopyr, see the Triclopyr (Acid, Choline salt, TEA salt, BEE): Draft Ecological Risk Assessment for Registration Review, which is available in the public docket. The EPA is currently working with its federal partners and other stakeholders to implement an interim approach for assessing potential risk to listed species and their designated critical 19 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov habitats. Once the scientific methods necessary to complete risk assessments for listed species and their designated critical habitats are finalized, the Agency will complete its endangered species assessment for triclopyr. See Appendix D for more details. As such, potential risks for non-listed species only are described below. 1. Risk Summary The following forms of triclopyr were assessed: triclopyr acid, triclopyr butoxyethyl ester (BEE), triclopyr choline (COLN), and triclopyr triethylamine salt (TEA). Triclopyr has a broad range of use sites, and application parameters vary depending on the use site. Table 2 details the application parameters assessed for each use site category in the 2019 ecological risk assessment. Table 2. Application parameters assessed by use site Use site Maximum single application rate Number of applications Retreatment interval Rice 0.375 lb ae/A 2 20 days Turf 1 lb ae/A 4 28 days Forestry 6 lb ae/A 1 Not specified on labels Non-crop areas, rights of ways 9 lb ae/A 1 Not specified on labels Pasture, rangeland 9 lb ae/A for spot treatment (labels specify 2 lb ae/A for wide area broadcast treatment) 1 Not specified on labels Aquatic weed control Calculated by equation present on the label, highest application is 5,000 ppb 1 Not specified on labels Tree cut stump 6 lb ae/A 1 Not specified on treatment labels The Agency originally assessed pasture and rangeland uses at a maximum rate of 9 lb ae/A in its 2019 risk assessment as some labels note this maximum rate for spot treatment of grazable land that intersects with non-crop areas and for individual plant treatment on grazable lands. However, the maximum labeled seasonal rate for wide area broadcast treatment of pasture and rangeland is 2 lb ae/A as noted on current labels. Pasture and rangeland are perennial cropping systems, so the maximum seasonal rate for wide area broadcast treatment is equivalent to the maximum yearly rate. As individual plant treatments on grazable lands and spot treatments, at a maximum rate of 9 lb ae/A, for grazable lands that intersect with non-crop areas are geographically limited, risk estimates for wide area broadcast application to pasture and rangeland at 2 lb ae/A is expected to more accurately reflect risk to non-target organism from 20 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov pasture/rangeland use on a broader scale. Revised risk estimates for pasture and rangeland are detailed in the Triclopyr: Response to Comments on the Draft Risk Assessment to Support Registration Review, also located in the public docket. Many of the high risk quotients (RQs) from triclopyr use are associated with the high maximum application rates ranging from 6 to 9 lb ae/A for uses in forestry, non-cropland areas, tree cut stump treatment, and rights of ways. Applications at these high rates are generally rare and when used, applications are highly localized and are done as brush treatment, basal bark treatment, stump treatment, hack and squirt treatment, frill or girdle treatment, and as spot treatment for targeted management of undesirable trees, shrubs, or other vegetation. Triclopyr can be applied via aerial applications in forestry settings but aerial applications are geographically limited and typically applied at a lower rate than the 6 lb ae/A rate assessed in risk assessment.9 Information gathered by USDA's Office of Pest Management Policy from the US Forest Service suggest that application of triclopyr in public forests occur at applications between 1-2 lb ai/A. Private foresters reported primarily using rates between 1-2.5 lb ai/A. An application rate of 1-2 lb ai/A is more common when applying triclopyr as a broadcast foliar treatment, aerial or ground, for the control of undesirable vegetation across forestry, non-cropland areas, and rights of ways use sites.10 The Agency concludes that risk to non-target organisms from use on forests, non-crop areas, and rights of ways is likely lower than estimated and is likely to be geographically limited. A summary of maximum RQs for triclopyr across use sites is detailed in Appendix A. Terrestrial Risks Mammals There are potential acute risks of concern to mammals with RQs ranging from <0.01 to 1.5 (level of concern, or LOC = 0.5) from all four triclopyr forms assessed (acid, TEA, COLN, and BEE). There are risk exceedances for non-crop areas and utility or road rights-of-way applications, which were assessed at the 6-9 lb ae/A rates. In the 2019 ecological risk assessment, pastures and rangeland uses, which were assessed at a maximum rate of 9 lb ae/A for only spot treatment of grazable lands that intersect with non-crop areas, also exceeded the LOC. At a maximum rate of 2.0 lb ae/A (which are for both spot treatment and wide area broadcast applications to pasture/rangeland), there are no acute risks of concerns for mammals. There are potential chronic risks of concern to mammals from the four triclopyr forms assessed with RQs ranging from 0.02 to 37.0 (LOC = 1.0). Chronic adverse effects observed in the 2- generation rat reproduction study included a 28 to 39% reduction in litter size, a 29 to 32% reduction in body weights for offspring, and a 17% reduction in pup survival. There are potential chronic risks of concern for the following uses: rice, turf, forestry, non-crop areas and rights of ways, and applications to pasture/rangeland at 2 lb ae/A or higher. 9 Unites States Department of Agriculture (USD A). 2020. Public Comment received from the USD A, Docket ID EPA-HQ-OPP-2014-0576-0030. Available at: hHps://www.regulations.gov/document?D=EPA-HO-OPP-2Q14- 0576-0030 10 USDA OPMP. 2020. Personal communication via e-mail with the United States Department of Agriculture Office of Pest Management Policy. 21 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov Birds. Reptiles, and Terrestrial-Phase Amphibians There are potential acute risks of concern to birds from the four triclopyr forms assessed with RQs ranging from <0.01 to 4.6 (acute risk LOC = 0.5). Acute dose-based RQs exceed the LOC for all uses but rice. Acute dietary-based RQs do not exceed the LOC with the exception of rights-of-way uses, where RQs are marginally above the acute risk LOC (max RQ = 0.74). Acute risks to birds are mostly associated with uses that have high maximum application rates (forestry, non-crop areas, and rights of ways, where application rates are 6.0- 9.0 lb ae/A). There are potential chronic risks of concern to birds from the assessed triclopyr forms with RQs ranging from 0.09 to 22 (LOC = 1.0) and there are risk exceedances for all uses. The chronic effect found was a 14% reduction in number of survivors. The higher chronic RQs (14 for forestry and 22 for non-crop areas and rights of ways) are mostly associated with high application rates between 6.0 - 9.0 lb ae/A. Chronic RQs up to 4.8 also exceed the LOC for applications to pasture/rangeland at 2.0 lb ae/A or above. Terrestrial Invertebrates (honey bees) The following uses were assumed to have possible exposure to pollinator attractive plants: residential turf (assuming the presence of blooming weeds), forestry, non-crop areas/rights of ways, and pasture/rangeland. The Tier 1 suite of laboratory-based acute and chronic toxicity data are available for triclopyr except for acute oral toxicity data for honeybee larvae11. The 8- day LDso value (i.e., dose at which 50% of the test population dies) from the available 22-day chronic larval toxicity study was utilized as a surrogate acute larval toxicity value in the risk assessment. While EPA did not identify risks of concern for acute contact exposure of adult honey bees, the Tier I assessment concludes that there is potential chronic risks of concern to adult bees (chronic adult RQs range from 2.3-20, based on 35% reduction in adult survival) and potential chronic risks of concern to larval bees (chronic larval RQs range from 23-211, based on 10%) reduction in emergence and 13% reduction in mortality). Potential chronic risks of concern to honeybees are indicated for all registered uses of triclopyr for triclopyr acid. Nine bee incidents have been reported for triclopyr, primarily associated with triclopyr TEA and BEE. The Agency assessed risk beyond the edge of the treated area to below toxicity threshold for adult bees and larval bees. For adult bees, potential chronic risks of concern extend from 7-184 feet from the application area, depending on the use pattern and the application rate. For larvae, potential chronic risks extend to 220 ft from the application area for turf use, and greater than 1,000 feet for forestry, parks, campgrounds, and rights-of-way uses. While chronic RQs for bees exceed the LOC for both adults and larvae, triclopyr is not applied to crops contracted for pollination services. Many of the uses for triclopyr are to non-pollinator attractive sites such as rice, aquatic weeds, industrial non-cropland sites, and as stump treatment for trees. There is possible exposure to pollinator attractive plants from applications to pasture/rangeland, forestry, rights-of-ways, and turf sites with flowering plants. The exposure to 11 An acute oral toxicity larval honeybee study report has been received and will be included in future analyses. 22 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov bees from these applications is likely to be spatially and temporally limited. The application of triclopyr will also likely cause the death of the target plant, which narrows the window of time that blooming flowers would be available for foraging. Given the pollinator risk concerns identified at the Tier I level for triclopyr, additional Tier II honeybee data are needed for triclopyr acid. A Tier II semi field testing requirement for pollinators (tunnel or colony feeding) study and Tier II field trial of residues in pollen and nectar study were included in the data call in (GDCI-116001-1546) and are needed based on the results from Tier I testing. These higher-tier data will help to refine the understanding of potential exposure of bees from these registered uses of triclopyr acid/TEA/COLN, and the extent of risk at the colony level. For triclopyr BEE, available laboratory and field-based fate studies indicate rapid transformation of triclopyr BEE to triclopyr acid in soil and aquatic systems (e.g., half life < 1 day). However, the rate of transformation of triclopyr BEE in (or on) plant tissues is uncertain. Should triclopyr BEE rapidly transform to the acid form in plant tissues, then no additional bee toxicity data would be needed for triclopyr BEE, because exposure and risk assessment would be based on the acid form. Available plant metabolism data for triclopyr are restricted to rice, which does not produce honeybee attractive nectar or pollen. However, if triclopyr BEE remains in (or on) bee- relevant plant tissues for durations considered toxicologically relevant (e.g., several days), additional Tier 1 honeybee toxicity data may be needed for triclopyr BEE. Therefore, data on the magnitude and persistence of triclopyr BEE in pollen and nectar is needed to refine the understanding of potential exposure of bees from these registered uses of triclopyr BEE. Terrestrial Plants As expected from an herbicide, there are potential risks of concern for terrestrial plants. Risks exceed the level of concern for all uses. Terrestrial plant RQs ranged from <0.1 to 17 for ground spray (where RQs above 1.0 exceed the LOC). RQs for aerial application also exceeded the LOC and ranged from 0.16 to 83. The Agency used spray drift modeling to determine the distance from the edge of the application where residues are below the toxicity threshold for both ground and aerial application. Risks extend from 14 to over 1,000 feet from the edge of the treated area for ground applications, and from 112 to over 1,000 feet from the edge of the treated area for aerial applications. Additionally, 49 terrestrial plant spray drift incidents have been reported to the Agency. Compost Contamination Crop injuries have been reported from mulch, grass clippings, straw/hay, manure, and compost contaminated with some pyridine herbicides. Depending on fate properties of the herbicide and environmental conditions, breakdown can occur in as few as 30 days, but some field reports indicate that breakdown can take as long as years. The herbicides of greatest concern are aminocyclopyrachlor, picloram, clopyralid, and aminopyralid because they can remain active in hay, grass clippings, piles of manure and compost for a long time. There are reported incidents of non-target plant damage from residues of pyridine herbicides in compost. These herbicides eventually break down through exposure to sunlight, soil microbes, heat, and moisture. 23 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov There have been no compost incidents reported with triclopyr alone. There is one compost incident involving a product containing both triclopyr and clopyralid, however it is unknown whether this incident is due to the presence of triclopyr or clopyralid or the interaction of both (incident number 1012701-001, see Appendix C of the ecological risk assessment for more information). There are data gaps for this route of exposure and uncertainty with respect to how triclopyr will dissipate and persist in compost. Due to persistence concerns for synthetic auxin pyridine herbicides, additional data are needed to assess the persistence of triclopyr in compost, the compost studies needed are: • A non-guideline compost kinetics study for vegetative material and manure • A modified guideline 835.6100 terrestrial field dissipation study that lasts 30 days • A non-guideline compost bioassay study for both vegetative material and manure. Aquatic Risks Fish No acute risks of concern were identified from any uses of triclopyr across all the forms assessed. There were no chronic risks of concern to fish with the exception of chronic risks to freshwater fish from the highest application (5,000 ppb) of triclopyr acid/TEA/COLN for aquatic weed control (RQ=1.8, LOC=1.0). The chronic effect seen was a 3% and 6% reduction in mean length and weight of fish. Aquatic Invertebrates No acute risks of concern were identified from any uses of triclopyr across all forms assessed. Chronic risks of concern are identified for freshwater invertebrates for the aquatic weed control use at the two highest application rates, 2,500 and 5,000 ppb of triclopyr acid/TEA/COLN, with RQ values of 3.0 and 6.0 respectively. The chronic effect seen was a 15 to 58% reduction in young females. For citrus stump treatment application, the RQ was identical to the LOC (RQ=1.0, LOC=1.0) for saltwater invertebrates in the water column. Aquatic Plants The aquatic plant LOC of 1.0 is exceeded slightly for non-vascular aquatic plants for aquatic weed control with triclopyr acid/TEA/COLN at the highest rate (5,000 ppb, RQ=1.2, LOC=1.0), and for citrus stump treatment (RQ=1.4, LOC=1.0). Although risk was indicated to non-vascular aquatic plants at the 9 lb ae/A rate assessed for rangeland/pasture, risks are not indicated at an application rate of 2 lb ae/A (which is the limit for wide area broadcast treatments to pasture and rangeland). Stump treatments and pasture/rangeland treatments at the 9 lb ae/A rate are spot treatments and are highly localized, as noted previously. For aquatic vascular plants, no risk exceedances were identified with any triclopyr product assessed. However, the tested species (i.e., duckweed) may differ in its sensitivity compared to rooted vascular plants, particularly targeted aquatic weeds, in part due to its different physiology. 24 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov Therefore, there may be some uncertainty for risk to vascular aquatic plants, particularly since triclopyr acid, TEA and COLN are registered for control of aquatic weeds. Ecological Incidents The Incident Data System (IDS) provides information on the available ecological pesticide incidents. A search of the Incident Data System (IDS) for triclopyr was conducted in May 2019. There are over 100 reported individual incidents from 1990 to 2019 in which triclopyr acid, TEA, or BEE products were applied and implicated in adverse effects to non-target organisms. Incidents are categorized according to the likelihood that use of triclopyr was associated the incident, and the classification categories are: unrelated, unlikely, possible {i.e., the pesticide possibly could have caused the incident but there are other possible explanations), probable {i.e., circumstances indicate that the pesticide was the cause, but confirming evidence is lacking), and highly probable {i.e., pesticide was confirmed as the cause through reliable evidence). Most incidents involved damage to non-target terrestrial and aquatic plants and were considered probable or possible in their causality classification. Nine incidents involved losses of honeybee hives and although triclopyr products were reported as being used in nearby areas, exposures were not verified by residue analysis. In no cases were bees killed immediately, but eventually {i.e., over time) hives failed. Two incidents involved fish kills near a rice field and a railroad crossing adjacent to a river. These fish incidents were classified as probable, but mortality was potentially from secondary effects (oxygen depletion from algae die off). In many of the triclopyr incidents, other herbicides were also used on site or triclopyr was applied as part of a mixed product containing another pesticide, so incidents could not be attributed to triclopyr alone. This was the case for one "probable" incident involving compost in 2002, where tomato seedlings exposed to contaminated compost showed stunted growth and leaf splitting.12 Triclopyr and clopyralid were implicated in the compost contamination but it was uncertain which pesticide or if the interaction of both pesticides caused the plant damage. The Agency will continue to monitor ecological incident information as it is reported to the Agency. Detailed analyses of these incidents are conducted if reported information indicates concerns for risk to non-target organisms. 2. Ecological and Environmental Fate Data Needs In support of registration review for triclopyr, a generic data call-in (GDCI-116001-1546) was issued, requiring the submission of several environmental fate and ecotoxicity studies. All required studies have been satisfied except for a guideline 850.2100 study and tier II honey bee studies. Guideline 850.2100 (avian acute oral toxicity study with a passerine bird) has been submitted and is currently in review. As previously noted, the results of Tier I honey bee risk assessment indicates chronic risk to larval and adult honey bees. The registration review GDCI noted that the requirement for higher tiered honeybee studies were dependent on the results of Tier I testing. The Agency concludes that these Tier II studies are needed in support of registration review for triclopyr acid: • a non-guideline field trial of residues in pollen and nectar and 12 See incident number 1012701-001 in Appendix C of the triclopyr ecological risk assessment. 25 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov • a non-guideline semi-field testing for pollinators (tunnel or colony feeding). EPA will evaluate these pollinator studies and determine if addition pollinator data needs to be generated. As mentioned above, in addition to the data required by GDCI-116001-1546, the following studies are needed to better understand the potential for triclopyr to contaminate compost: • a modified guideline 835.6100 terrestrial field dissipation study with a duration of at least 30 days, • a non-guideline compost kinetics study for vegetative material and manure, and • a non-guideline compost bioassay studies for both vegetative material and manure. C. Benefits Assessment Use of triclopyr provides benefits in both agricultural and non-agricultural settings. Triclopyr provides benefits to users in pasturelands and rangeland due to its excellent control of numerous woody and broadleaf weed species, such as mesquite and catclaw, that are commonly problematic in these sites. A unique benefit of pyridine herbicides, such as triclopyr, is that they are more selective compared to other effective broad-spectrum herbicides. This characteristic allows land managers to maintain desirable forage and shrub species in the landscape to serve as shade and forage for grazing livestock. Triclopyr is used as a cut-stump and basal bark application in these settings to control dogfennel, honeysuckle, blackberry, honey-locust, buckeye, oaks, willow pine, sumac, mixed brush, and other undesirable plants. Alternatives used in pasture/rangeland management are other pyridine herbicides, such as picloram and clopyralid. Triclopyr is considered essential by the United States Forest Service13 for the control of invasive plant species such as bush honey suckle, tamarisk, and Siberian elm in the management of public lands. The USDA Animal and Plant Health Inspection Service14 noted benefits as well as for stump and root removal in control attempts for invasive insect species including Asian long- horned beetle and spotted lanternfly. Triclopyr is also important for conifer site preparation and conifer release treatments and offers selective control so it does not damage desirable tree species while controlling undesirable weeds and shrubs. Triclopyr is also used by private foresters for site preparation, stand management, and habitat management in silviculture. Private foresters like triclopyr for its versatility and its specificity. Triclopyr is used to control noxious or invasive plants and to control un-wanted brush in the forest understory. In the southeast and northeast, triclopyr is mainly applied by helicopter in timber stands that are too remote to access with vehicles or applied by vehicle-mounted mechanically pressurized handgun or backpack sprayer. Alternatives in forestry management are: aminopyralid, glyphosate, hexazinone, imazapyr, and sulfometuron-methyl. 13 See information from the United States Forest Service in the triclopyr registration review docket (EPA-HQ-OPP- 2014-0576), available at: httDs://beta.regulations.gov/document/EPA-HO-OPP-2014-0576-0039 14 See comment submitted by USDA in triclopyr registration review docket (EPA-HQ-OPP-2014-0576), available at: https://befa.regiilations.gov/coniment/EPA-HO-OPP-2014-0576-0030 26 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov In golf courses and other turf sites, triclopyr is considered safe for use on a variety of turfgrass species for the selective postemergence control of numerous annual and perennial broadleaf weed species. Alternative herbicides used in turf management are 2,4-D, dichlorprop, mecoprop, dicamba, and clopyralid. In non-croplands, triclopyr is recommended for the control of broadleaf weeds, vines, brush, and trees using foliar treatment, basal bark, cut surface, and cut stump applications. Selective control is more important in non-cropland use sites such as fencerows and rights-of-way as opposed to industrial sites which are often left bare ground. These areas can contain both desirable and non- desirable plants which makes the use of a selective herbicide like triclopyr important. Other selective herbicides used in non-cropland settings include picloram and dicamba. Other herbicides used for basal bark applications in these areas include 2,4-D; however, triclopyr has really become the primary herbicide for this application method since it is a more selective chemical that prevents damage to nearby desirable tree species. For additional information on the benefits of triclopyr, see the document Usage, Benefits and Alternatives for Triclopyr. IV. INTERIM REGISTRATION REVIEW DECISION A. Risk Mitigation and Regulatory Rationale The Agency has reviewed the risks and benefits associated with the registered uses of triclopyr in developing this Interim Registration Review Decision. EPA has determined that the only potential human health risk of concern is to occupational handlers mixing/loading liquid products for aerial forestry applications. To mitigate this risk EPA has determined it is necessary for a PF- 10 respirator to be worn by mixers and loaders for aerial application via helicopter for forestry use. The Agency identified potential risks to non-target terrestrial plants from spray drift and runoff. There were also potential risks to mammals, birds, terrestrial invertebrates, aquatic invertebrates, and aquatic plants. It is necessary for mandatory spray drift management measures to be put on labels to reduce risks to non-target organisms. Triclopyr is a synthetic auxin and has structural similarity to other pyridine herbicides with known compost incidents. The potential for triclopyr to persist in compostable plant material and manure and pose risks of concern is an uncertainty. The Agency is adding compost labeling for certain persistent herbicides based on a weight of evidence approach. Based on its toxicity to non-target terrestrial plants, its fate properties (it is highly mobile, is stable to hydrolysis, and can leach to groundwater), and its structural similarity to herbicides known for compost contamination, it is necessary for product labels to reflect new labeling intended to prevent treated plant materials from entering the compost stream. EPA is also planning to call in additional data for triclopyr to evaluate the potential for compost contamination. Further, it is necessary that labels provide herbicide resistance management information and that registrants update all labels to meet current standards. 27 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov 1. Respirator for Mixers/Loaders for Aerial Forestry Use To mitigate potential inhalation risk to occupational handlers, a respirator for pesticides covered by the Worker Protection Standard15 (WPS), and the associated fit test, training, and medical evaluation is necessary for the following scenario: • mixers and loaders using liquid products in aerial forestry applications via helicopter Fit testing, training, and medical evaluations16 are necessary for all handlers who are required to wear respirators for aerial forestry applications via helicopter.17 If a triclopyr handler currently does not use a respirator, an additional cost will be incurred by the handler or the handler's employer, which includes the cost of the respirator plus, for WPS-covered products, the cost for a respirator fit test, training, and medical exam. Respirator costs are extremely variable depending upon the protection level desired, disposability, comfort, and the kinds of vapors and particulates being filtered. Based on available information, the cost of the respirators (whether disposable or reusable) is relatively minor in comparison to the fit-test requirement under the Worker Protection Standard. The Agency expects that the average cost of a particulate filtering facepiece respirator is lower than the average cost of an elastomeric half mask respirator. In 2015, the estimated cost of a respirator fit test, training and medical exam is about $180 annually.18 However, if a triclopyr handler typically uses other chemicals requiring a respirator in the production system or as part of the business, additional fit testing is not needed. The handler or employer may only incur the cost of purchasing filters for the respirator on a more frequent basis. Respirator fit tests are currently required by the Occupational Safety and Health Administration (OSHA) for other occupational settings to ensure proper protection.19 The EPA acknowledges that requiring a respirator and the associated fit testing, training, and medical evaluation places a burden on handlers or employers. However, the proper fit and use of respirators is essential to accomplish the protections respirators are intended to provide. In estimating the inhalation risks, and the risk reduction associated with different respirators, the EPA's human health risk assessments assume National Institute for Occupational Safety and Health (NIOSH) protection factors {i.e., respirators are used according to OSHA's standards). If the respirator does not fit properly, use of triclopyr may cause unreasonable adverse effects on the pesticide handler. 15 40 CFR 170 16 Fit testing, training, and medical evaluations must be conducted according to OSHA regulations 29 CFR § 1910.134, 29 CFR § 1910.134(k)(l)(i) through(vi), and 29 CFR § 1910.134, respectively. 17 40 CFR 170 (see also Appendix A of Chapter 10 of the Label Review Manual, available at https://www.epa.gi3v/pesficicie-regisfration/label-review-mannan 18 Economic Analysis of the Agricultural Worker Protection Standard Revisions. Biological and Economic Analysis Division, Office of Pesticide Programs, U.S. EPA. 2015. p. 205. Available at www.regiilations.gov. docket number EPA-HQ-OPP-2011-0184-2522 19 29 CFR S 1910.134 28 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov With the addition of a respirator for mixers and loaders for triclopyr aerial forestry applications via helicopter, there are no risks of concern for other occupational handler scenarios. The addition of a respirator for this use also potentially reduces the need for a subchronic inhalation toxicity study. With the exception of the costs outlined above associated with training, fit testing, and medical exam, the addition a respirator is expected to cause minimal economic impact on users. Aerial forestry application via helicopter is geographically limited and mixers/loaders for aerial application would likely already have access to respirators. 2. Updated Gloves Statement It is necessary to update the gloves statements to be consistent with Chapter 10 of the Label Review Manual. In particular, it is necessary for the removal of references to specific categories in EPA's chemical-resistance category selection chart and that labels specify the appropriate glove types to use. For example, this statement from the label is to be removed: "For more options, follow the instructions for Category A on the chemical-resistance category selection chart." 3. Measures to Address Potential Compost Concerns Triclopyr is a pyridine herbicide and a synthetic auxin. Some herbicides in the pyridine class have been found to persist in compost and there are reported incidents of damage to non-target terrestrial plants. Herbicides such as aminopyralid, picloram, and clopyralid have been found to persist at phytotoxic levels for long periods of time, from months to years. Pyridine herbicides can contaminate compost via treated plant material or manure from animals that have grazed on treated areas that then enters a composting facility. Once a compost facility is contaminated it can impact many end users through the sale of this compost. Residues in contaminated compost can cause stunting or abnormal growth of plants exposed to the compost. Currently there are limited data on the persistence of triclopyr in compost, and there have been no reported incidents of compost contamination involving triclopyr alone. There is one incident reported of non-target plant damage from compost involving a mixed triclopyr and clopyralid product, but there are additional compost incidents reported with clopyralid. However, the low number of incidents does not necessarily indicate that there is no potential risk of compost contamination. The Agency is considering compost labeling for some synthetic auxins based on a weight of evidence approach, which include the following considerations: o Incident data, o Fate data indicating stability to hydrolysis and high mobility (i.e., ability to leach from finished compost), o Toxicity to non-target terrestrial plants, o Structural similarity to pesticides with known compost issues, and other lines of evidence. 29 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov Based on triclopyr's fate properties such as its ability to leach and it being highly mobile, its toxicity to non-target terrestrial plants, and its structural similarity to herbicides with known compost issues, the Agency concludes that triclopyr may have the potential to contaminate compost. To address potential composting concerns, a statement instructing users not to transport offsite treated plant materials (e.g., hay, turf clippings) or manure from animals that have grazed in treated areas for compost until 30 days after application is necessary. A clean out period for livestock that have grazed on treated lands is also necessary. EPA is also only requiring this compost mitigation language and animal clean out time on labels with pasture and turf uses, since these uses sites are thought to be most likely to attribute treated materials to the compost stream. The following compost statements are required for pasture and turf uses: "This product is persistent and may be present in treated plant materials for over 30 days after application. Do not sell or transport treated plant materials or manure from animals that have grazed on treated plant materials off-site for compost distribution or for use as animal bedding/feed for 30 days after application. Animals that have been fed triclopyr treated forage must be fed forage free of triclopyr for at least 3 days before movement to an area where manure may be collected, or sensitive crops are grown." The Agency assessed the potential impacts to triclopyr users from these restrictions. Users may experience increased difficulty in disposing of hay, grass clippings, and excess manure. Livestock managers may have to treat only a portion of a site to have an adequate untreated area for livestock to graze in during the 3-day clean out period or may have to provide additional forage. Users might switch to an alternative without compost restrictions, which could be more costly and less efficacious. The magnitude of the impacts on individuals is uncertain and may be highly variable depending on circumstances. The EPA needs compost data for triclopyr to improve our understanding of the potential for compost contamination. Compost data being required are: o a modified guideline 835.6100 terrestrial field dissipation study with a duration of at least 30 days, o a non-guideline compost kinetics study for vegetative material and manure, and o a non-guideline compost bioassay study for both vegetative material and manure The Agency will review the need for compost labeling in future decisions, considering any new compost data available. The results from the on-field dissipation study will determine if the compost kinetics and compost bioassay studies are needed. If on-field dissipation study shows that residues dissipate rapidly after application and are not of concern, the compost kinetics and compost bioassay studies are not needed. 4. Spray Drift Management Label changes to reduce off-target spray drift and establish a baseline level of protection against spray drift that is consistent across all triclopyr products are necessary. Reducing spray drift will 30 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov reduce the extent of environmental exposure and risk to non-target plants and animals. Although the Agency is not making a complete endangered species finding at this time, these label changes are expected to reduce the extent of exposure and may reduce risk to listed species whose range and/or critical habitat co-occur with the use of triclopyr. The following spray drift mitigation language is to be included on all triclopyr product labels for products applied as liquid spray application. The spray drift language is intended to be mandatory, enforceable statements and supersede any existing language already on product labels (either advisory or mandatory) covering the same topics. The Agency is also providing recommendations which allow triclopyr registrants to standardize all advisory language on triclopyr product labels. Registrants must ensure that any existing advisory language left on labels does not contradict or modify the new mandatory spray drift statements necessary for this ID, once effective. • Applicators must not spray during temperature inversions. • For aerial applications, do not apply when wind speeds exceed 15 mph at the application site. If the windspeed is greater than 10 mph, the boom length must be 65% or less of the wingspan for fixed wing aircraft and 75% or less of the rotor diameter for helicopters. Otherwise, the boom length must be 75% or less of the wingspan for fixed-wing aircraft and 90% or less of the rotor diameter for helicopters. • For aerial applicators, if the windspeed is 10 miles per hour or less, applicators must use '/2 swath displacement upwind at the downwind edge of the field. When the windspeed is between 11-15 miles per hour, applicators must use 3/4 swath displacement upwind at the downwind edge of the field. • For aerial applications, the release height must be no higher than 10 feet from the top of the crop canopy or ground, unless a greater application height is required for pilot safety. • For ground boom applications, apply with the release height no more than 4 feet above the ground or crop canopy. • For ground boom-less application (e.g., roadsides, rights of ways) there will be no mandatory release height restrictions due to equipment having physical limitations for achieving a height of 4 feet. There will be advisory spray drift language informing applicators to set nozzles at the lowest effective height to help reduce the potential for spray drift. The droplet size for these applications are also typically coarser, thus reducing the risk of spray drift. • For ground applications, do not apply when wind speeds exceed 15 miles per hour at the application site. • Applicators are to select a nozzle and pressure combination that delivers a medium or coarser droplet size (AS ABE S572 for ground applications and AS ABE S641 for aerial applications). In addition to including the spray drift restrictions on triclopyr labels, all references to volumetric mean diameter (VMD) information for spray droplets are to be removed from all triclopyr labels where such information currently appears. The new language above, which cites ASABE S572 for groundboom equipment and ASABE S641 for aerial equipment, eliminates the need for VMD information. Impacts of Syr ay Drift Mitigation 31 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov Temperature Inversion The requirement could result in delays to intended applications and, more generally, reduce the amount of time users have to apply triclopyr. Potentially, growers could switch to a different active ingredient that does not have this restriction, but that would be costly and potentially difficult to obtain in a short period of time. Wind Speed A 15-miles per hour (mph) wind speed restriction for ground and aerial applications of triclopyr is being required for all labels. Some, but not all triclopyr labels currently contain these wind speed restrictions and therefore some users may be impacted by the requirement. Wind conditions vary across the U.S. and wind speed restrictions could prevent timely applications of triclopyr. Survey data (Bish and Bradley, 2017)20 indicate that most applicators consider wind speed when making applications and typically apply at wind speeds of 15 mph or lower. However, there are situations when applicators will spray at wind speeds greater than 15 mph (these applicators account for less than 10% of survey respondents). Mandatory wind speed restrictions potentially complicate weed and crop management by reducing the available time to make applications and make it more likely that a grower may need to alter pest control plans. Users may switch to other products that do not have this restriction if they regularly encounter wind speeds over 15 mph during the application season. The Agency also notes that some users have already limited use of pesticides during low wind speeds. For instance, nursery, ornamental and turf applicators generally have mixtures of many plant species in the general application area and must be precise in application to avoid off-site movement and resulting phytotoxicity damage to their stock. Therefore, impacts of the a windspeed restriction may be minimal to these users because they would normally apply only under relatively calm conditions. Release Height Triclopyr labels do not have any required maximum release height for ground boom applications. Spray release height is important to minimize overlap of spray from nozzles while maintaining proper coverage. If nozzles are placed too low, the application may not provide adequate coverage which could lead to portions of the field not receiving pesticide. The Agency reviewed manufacturer recommendations and found21 that a release height of 4 feet allows adequate 20 Bish, M. and K.W. Bradley. 2017. Survey of Missouri Pesticide Applicator Practices, Knowledge, and Perceptions. Weed Technology 31:165-177. Available at: https://weedscience.niissonri.edu/Pesticide%20Applicator%20Knowledge [ 21 Tindall, K. and C. Hanson. 2018. Qualitative Benefits and Usage Assessment of Diflufenzopyr (PC Code 005108) and Diflufenzopyr-Sodium (PC Code 005107). Available at: https://www.regulations.gov/document?D=EPA-HO-OPP-2Ql.1.-09.1. .1.-0022 32 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov coverage for the majority of nozzles. Therefore, the EPA does not anticipate any negative impacts to growers from the requirement. For aerial applications, the Agency considers a release height of 10 feet from the top of the crop canopy or ground to be standard application practice and does not anticipate any negative impacts from the requirement. Droplet Size The Agency is establishing a mandatory droplet size of "medium or coarser," as defined by AS ABE S572 for groundboom equipment and AS ABE S641 for aerial equipment, for triclopyr. Currently triclopyr labels have only advisory language for droplet size. Based on a previous 2017 Agency analysis22, several factors (e.g., droplet formation at the nozzle, retention on the leaf surface, deposition of the active ingredient, the resulting biological response, environmental conditions, etc.) can impact the efficacy of an herbicide application, including droplet size. Generally, the Agency concludes there will be lower impacts associated with larger droplet sizes (i.e., medium or coarser) with systemic herbicides than with contact herbicides in regard to efficacy. However, despite being translocated in plants, triclopyr must contact foliage for effective weed management. Therefore, requiring medium or coarser droplets may affect the efficacy of triclopyr when triclopyr is used alone. A droplet size of medium or coarser could reduce the flexibility of pesticides co-applied with other pesticides (e.g., herbicides, insecticides) that require a smaller droplet size, requiring farmers to make two separate applications (one for each droplet size) or reducing efficacy of other pesticides co-applied with triclopyr that require smaller droplet sizes to be effective. If reduced efficacy occurred with tank mixed herbicides or insecticides, the Agency would expect growers to respond by increasing the application rates (if allowed by the label), increasing the number of applications, increasing the application rates of tank mix partners, making additional herbicide applications with other herbicides, or changing to a different herbicide. 5. Non-Target Organism Advisory The Agency is also adding a non-target organism advisory on labels. The protection of pollinating organisms is a priority for the Agency. Use of triclopyr may negatively impact forage and habitat of pollinators and other non-target organisms. It is the Agency's goal to reduce spray drift whenever possible and to educate growers on the potential for indirect effects on the forage and habitat of pollinators and other non-target organisms. Therefore, a non-target organism advisory language is necessary to be placed on triclopyr's labels to address this potential concern. See Appendix C for the statement. 22 Chism, B., J. Becker, C. Hawkins, and S. Smearman. 2017. Effects of Mandatory Spray Droplet Size Category on Herbicide Efficacy and Crop Yield: Potential Impacts on Sulfonylurea-Registered Crops. hHps://www.regulations.eov/document?D=EP A-HO-OPP-20.1. .1.-0994-0057 33 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov 6. Herbicide Resistance Management On August 24, 2017, the EPA finalized a Pesticide Registration Notice (PRN) on herbicide resistance management.23 Consistent with the Notice, the implementation of herbicide resistance measures for existing chemicals during registration review, and for new chemicals and new uses at the time of registration is necessary. In registration review, herbicide resistance elements will be included in every herbicide ID. The development and spread of herbicide resistant weeds in agriculture is a widespread problem that has the potential to fundamentally change production practices in U.S. agriculture. While herbicide resistant weeds have been known since the 1950s, the number of species and their geographical extent, has been increasing rapidly. Currently there are over 250 weed species worldwide with confirmed herbicide resistance. In the United States, there are over 155 weed species with confirmed resistance to one or more herbicides. Management of herbicide resistant weeds, both in mitigating established herbicide resistant weeds and in slowing or preventing the development of new herbicide resistant weeds, is a complex problem without a simple solution. Coordinated efforts of growers, agricultural extension, academic researcher, scientific societies, pesticide registrants, and state and federal agencies are required to address this problem. The EPA is requiring measures for the pesticide registrants to provide growers and users with detailed information and recommendations to slow the development and spread of herbicide resistant weeds. This is part of a more holistic, proactive approach recommended by crop consultants, commodity organizations, professional/scientific societies, researchers, and the registrants themselves. 7. Environmental Hazards a. Fish and Aquatic Invertebrates Statement for BEE Products On an acute exposure basis, triclopyr BEE is consistently 2 to 3 orders of magnitude more toxic to aquatic animals compared to triclopyr acid or TEA. This has led to many triclopyr BEE product labels having an aquatic organism hazard statement. The Agency has determined that it is necessary to apply this statement across all the triclopyr BEE labels. The statement will warn that the product may be hazardous to fish and aquatic invertebrates. Please see Appendix C for the full statement. b. Aquatic Weed Control Statement 23 PRN 2017-2, "Guidance for Herbicide Resistance Management Labeling, Education, Training, and Stewardship". Available at https://www.epa.gov/pesficide-regisfrafion/pesficicie-regisfration-nofices-vear 34 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov Some triclopyr products are used to treat invasive aquatic plants and other aquatic weeds. In accordance with guidance in EPA's label review manual, an aquatic weed control statement is necessary for all triclopyr products with direct applications to water. The aquatic weed control statement will warn users of the potential for fish suffocation from oxygen loss from decomposition of dead weeds and require applicators to not treat more than half of the water body in a single application and wait at least 14 days between treatments. It also instructs applicators to begin treatment along the shore and proceed outward in bands to allow for fish movement. Please see Appendix C for the full statement. c. Surface Water Advisory Triclopyr has been detected in surface water monitoring data. Triclopyr's fate properties suggest that it has a high potential to reach surface water. For this reason, it is necessary for a surface water advisory to be placed on all triclopyr labels to address this potential concern. The statements are consistent with guidance in EPA's label review manual. Non-agricultural labels will need to have a general statement that the triclopyr product can impact surface water quality through runoff. For products with agricultural uses, additional advisory text is needed on the benefits of vegetated buffer strips and avoiding applications within two days of expected rainfall or irrigation. The statements are noted in Appendix C. d. Ground Water Advisory Triclopyr has been detected in groundwater monitoring data. In addition, triclopyr has environmental fate properties that indicate it has the potential to persist in groundwater. For this reason, a groundwater advisory is necessary to be placed on all triclopyr labels to address this potential concern. This language will warn that triclopyr products have the potential to leach into groundwater. Please see Appendix C for the full statement. 8. Clarification of Application Rates a. Grazable Areas Intersecting with Treated Non-Cropland, Rights of Way, and Forestry sites The triclopyr labels include a 2 lb ae/A per season maximum application rate for pasture, rangelands, and any other areas which are grazed. Some labels have an exception that allow for higher application rates (up to 8 lb ae/A) in grazed areas that intersect treated non-cropland, rights-of-way, and forestry sites if the application comprises no more than 10% of the total grazable area. The intention of this exception is to allow for applicators to make spot treatments on public easements. Language on current labels read as follows: "Portions of grazed areas that intersect treated non-cropland, rights-of-way and forestry sites may be treated at up to 8 lb ae per acre if the area to be treated on the day of application comprises no more than 10% of the total grazable area." 35 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov The current text may be unclear for some users. The Agency has determined that it is necessary for the existing language to be revised to clarify the maximum single application rate for non- cropland, rights-of-way, and forestry sites that intersect grazed areas: "The maximum application rate for spot treatments on non-cropland, rights-of-way, and forestry sites that intersect grazed areas is 8 lb ae /A/year. Spot treatment applications at rates over 6 lb ae/A must not use aerial or broadcast ground boom application equipment." b. Maximum Application Rates Some labels lack adequate information on the maximum application parameters. Labels frequently do not specify the maximum yearly rate and list only seasonal rates. EPA needs labels that include clear maximum single rates, maximum yearly rates, and minimum retreatment intervals. In discussions with the Agency on May 6, 2020, Corteva Agriscience, one of the technical registrants for triclopyr, notes that the information noted in Table 3 are the maximum application parameters being supported for uses on the labels: Table 3. Maximum App ication Parameters by Use Site Use site Maximum single application rate (lb ae/A) Maximum yearly application rate (lb ae/A) Minimum retreatment interval (days) Pasture and rangeland 2 2 28 Spot treatment on non-cropland, rights of way, and forestry sites that intersect grazed areas (e.g., public easements) 8 8 28 Forestry 6 6 28 Non-crop areas (including rights of ways, fencerows, and similar areas) for triclopyr TEA 9 9 28 Non-crop areas (including rights of ways, fencerows, and similar areas) for triclopyr BEE 8 8 28 Turf and ornamentals 1 4 28 Foliar applications to floating/emerged weeds in aquatic water bodies 6 6 14 36 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov No additional comments were received on these rates during the PID public comment period and the Agency expects limited impact from the label clarifications, as the current use parameters are not being altered. The 2 lb ae/A per season rate for pasture/rangeland needed to be converted to a yearly rate, but this change is not expected to have impact on users because pasture and rangeland are typically perennial cropping systems and therefore a seasonal rate is equivalent to an annual rate. c. Aquatic Applications For direct applications to water for aquatic weed control, some of the labels do not specify the average depth/area of the water body or lb ae/A-foot of water to be treated to arrive at the effective concentration necessary to kill weeds. The rates for aquatic weed control should include the appropriate units associated with these applications (acre-foot) and also reflect the appropriate depth and area of the water body to help add clarity to the label. The addition of a table that provides information on rates expressed via depth and surface area is necessary. Table 4 provides an example of how rates are to be expressed (gallons specified per surface area at specific depths are merely for demonstration purposes and are not part of EPA labeling). The following labels, and any other labels that allow for aquatic application, may need to update their label in accordance to this label clarification: 62719-687, 5905-580, 67690-50, 42750-127, 42750-243, 62719-187, 62719-37, 67690-42, 67690-50, 70506-228, 81927-13. Table 4. Example table of application rates expressed as gallons via depth and surface area Concentration of Triclopyr Acid in Water (ppm ae) Water Depth (ft) 0.75 ppm 1.0 ppm 1.5 ppm 2.0 ppm 2.5 ppm Gallons of Product per Surface Acre at Specified Depth 1 0.7 0.9 1.4 1.8 2.3 2 1.4 1.8 2.7 3.6 4.6 3 2.1 2.7 4.1 5.4 6.8 4 2.7 3.6 5.4 7.2 9.1 5 3.4 4.5 6.8 9.0 11.3 6 4.1 5.4 8.1 10.9 13.6 7 4.8 6.3 9.5 12.7 15.8 8 5.5 7.2 10.9 14.5 18.1 9 6.1 8.1 12.2 16.3 20.4 10 6.8 9.0 13.6 18.1 22.6 15 10.2 13.6 20.4 27.2 33.9 20 13.6 18.1 27.2 36.2 45.3 B. Tolerance Actions 37 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov The Agency anticipates revising several tolerances for triclopyr to be consistent with updated commodity definitions and current rounding practices. Please refer to Section III. A 3 for more details. The Agency will use its FFDCA rulemaking authority to make the anticipated changes to the tolerances. C. Interim Registration Review Decision In accordance with 40 CFR § 155.56 and 155.58, the Agency is issuing this ID. Except for the Endocrine Disruptor Screening Program (EDSP) and the Endangered Species Act (ESA) components of this case, the Agency has made the following interim decision: additional data are required and changes to the affected registrations and their labeling are needed at this time, as described in Section IV. A and Appendices B and C. In this ID, the Agency is making no human health or environmental safety findings associated with the EDSP screening of triclopyr, nor is it making a complete endangered species finding. Although the Agency is not making a complete endangered species finding at this time, the mitigation described in this document is expected to reduce the extent of environmental exposure and may reduce risk to listed species whose range and/or critical habitat co-occur with the use of triclopyr. The Agency's final registration review decision for triclopyr will be dependent upon the result of the Agency's ESA assessment and any needed § 7 consultation with the Services and an EDSP FFDCA § 408(p) determination. D. Data Requirements A Generic Data Call-In (GDCI-116001-1546) was issued for triclopyr for data needed to conduct the registration review risk assessments. All data requirements have been satisfied, except for the following: • guideline 850.2100 avian acute oral toxicity study with a passerine bird (MRID 50294201 is currently in review) • non-guideline residues in pollen and nectar/field residue analysis (Tier II) • non-guideline semi-field testing for pollinators (tunnel or colony feeding, Tier II) A guideline 870.3465 90-day inhalation toxicity study was also required as part of the triclopyr registration review GDCI (GDCI-116001-1546). Although this study has not been submitted, when a respirator requirement is added on labels to protect mixers/loaders for aerial forestry application via helicopter, the Agency will consider waiving the 90-day inhalation toxicity data requirement. The EPA has determined Tier II honey bee data for triclopyr acid and BEE are needed, based on the results of the Tier 1 data {i.e., laboratory studies) and other lines of evidence. See Section III. B. 3. Ecological and Environmental Fate Data Needs for additional detail. Due to the uncertainty regarding triclopyr's ability to persist in compost, the EPA will be requiring the following compost studies: 38 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov o a modified guideline 835.6100 terrestrial field dissipation study with a duration of at least 30 days, o a non-guideline compost kinetics study for vegetative material and manure, o a non-guideline compost bioassay study for both vegetative material and manure. The Agency intends to issue a data call-in to require these compost studies. If on-field dissipation study shows that residues dissipate rapidly after application and are not of concern, the compost kinetics and compost bioassay studies are not needed. V. NEXT STEPS AND TIMELINE A. Interim Registration Review Decision A Federal Register Notice will announce the availability of this interim decision for triclopyr. A final decision on the triclopyr registration review case will occur after: (1) an EDSP FFDCA § 408(p) determination and (2) an endangered species determination under the ESA and any needed § 7 consultation with the Services. B. Implementation of Mitigation Measures Once the Interim Registration Review Decision is issued, the triclopyr registrants must submit amended labels that include the label changes described in Appendices B and C. The revised labels and requests for amendment of registrations must be submitted to the Agency for review within 60 days following issuance of the Interim Registration Review Decision. Registrants must submit a cover letter, a completed Application for Registration (EPA form 8570-1) and electronic copies of the amended product labels. Two copies for each label must be submitted, a clean copy and an annotated copy with changes. In order for the application to be processed, registrants must include the following statement on the Application for Registration (EPA form 8570-1): "I certify that this amendment satisfies the requirements of the Triclopyr Interim Registration Review Decision and EPA regulations at 40 CFR Section 152.44, and no other changes have been made to the labeling of this product. I understand that it is a violation of 18 U.S.C. Section 1001 to willfully make any false statement to EPA. I further understand that if this amendment is found not to satisfy the requirements of the Triclopyr Interim Registration Review Decision and 40 CFR Section 152.44, this product may be in violation of FIFRA and may be subject to regulatory and/or enforcement action and penalties under FIFRA." Within the required timeframe, registrants must submit the required documents to the Re- evaluation section of EPA's Pesticide Submission Portal (PSP), which can be accessed through EPA's Central Data Exchange (CDX) using the following link: https://cdx.epa.gov/. Registrants may instead email or send paper copies of their amended product labels, with an application for a fast-track, agency-initiated non-PRIA label amendment to Andrew Muench, so long as the labels 39 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov and application are submitted within the required timeframe. Registrants who wish to submit label amendments via paper copy must contact Andrew Muench at muench.andrew@epa.gov to make the necessary arrangements. 40 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov Appendix A: Summary of Maximum RQs for Triclopyr by Use Site A= =acute RQ; C=chronic RQ; Ar=aerial RQ; Gr=ground RQ Use site Mammals Birds, reptiles, and terrestrial phase amphibians Terrestrial invertebrates Aquatic Invertebrates Fish Terrestrial plants Aquatic plants Rice A=0.1 C=2.6 A=0.19 C=1.5 n/a n/a n/a Ar=3.5 Gr=0.069 n/a Turf A=0.35 A=l.l A<0.11 A=.03 n/a Ar=9.3 0.1 C=8.7 C=5 C=23 C=.14 Gr=1.85 Forestry A=0.99 A=3.1 A<0.16 A=0.13 n/a Ar=55 0.5 C=25 C=14 C=141 C=0.6 Gr=l 1 Non-crop areas, A=1.5 A=4.6 A<0.24 A=0.16 n/a Ar=83 0.6 rights of ways, spot C=37 C=22 C=211 C=0.6 Gr=17 treatment of grazable land intersecting with non-crop areas Pasture and A=0.33 A=1.03 A<0.65 A=0.17 A=0.74 19 0.59 rangeland C=3.0 C=4.8 C=47 C=0.6 C=0.54 (applications at 2 lb ae/A rate) Aquatic weed n/a n/a n/a A=0.04 A=0.04 n/a 1.2 control C=6.0 C=1.8 Cut Stump n/a n/a n/a A=0.4 n/a n/a 1.4 Treatment C=1.0 • Terrestrial mammals, birds: Acute LOC=0.5; Chronic LOC=1.0 • Terrestrial Invertebrates: Acute LOC=0.4; Chronic LOC=1.0 • Aquatic Animals: Acute=0.5; Chronic=1.0 • Terrestrial and Aquatic Plants: LOC=1.0 41 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov Appendix B: Summary of Risk Mitigation for Triclopyr Registration Review Case #: 2710 PC Codes: 116000 116001. 116002. 116004 Chemical Type: Herbicide Chemical Family: Pyridine carboxylic acid Mechanism of Action: mimics naturally occurring plant hormones, therebv disrupting growth Affected Population(s) Source of Exposure Route of Exposure Duration of Exposure Potential Risk(s) of Concern Actions Mixers/Loaders for aerial forestry application via helicopter Aerial application Inhalation Short- and inlermcdiate-lcrm Acute toxicity Addition of respirator for workers mixing/loading for aerial forestry application via helicopter Terrestrial Plants Spray Drift and runoff, residues in compost Foliar absorption, plant uptake N/A Growth, bio mass Enforceable spray drift reduction measures Instructions for the user not to transport offsile treated plant material or manure from animals grazing in treated areas for compost for 30- dav s after application Grazing animal clean out period of 3 days Mammals Application to crops. Sprav Drift Dietary Acute, chronic Litter si/.c. offspring weight, and offspring survival Enforceable spray drift reduction measures Birds. Reptiles. Terrestrial Amphibians Application to crops. Spray Drift Dietary Acute, chronic Offspring survival Enforceable spray drift reduction measures Terrestrial Pollinators Spray Drift Dietary Acute, chronic Adult and offspring survival, and offspring emergence Enforceable spray drift reduction measures Freshwater Fish Aquatic Application, runoff Ingestion. Dermal absorption Chronic Growth. Biomass Fish and aquatic invertebrate statement Surface water advisory Freshwater Invertebrates Aquatic Application, runoff Ingestion. Dermal absorption Chronic Amount of offspring Fish and aquatic invertebrate statement Surface water advisory Estuarine/Marinc Invertebrates (Water Column) Aquatic application. Runoff Ingestion Dermal. absorption Chronic Biomass Fish and aquatic invertebrate statement. Surface water advisory Aquatic Non-Vascular Plants Aquatic Application. Runoff Plant Uptake N/A Biomass Aquatic weed control statement Surface water advisory 42 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov Appendix C: Labeling Changes for Triclopyr Products Description l.ahcl Language lor Iriclopv r Products Placement on l.ahcl End Use Products Site of Action Group Number Note to registrant: • Include the name of the ACTIVE INGREDIENT in the first column • Include the word "GROUP" in the second column • Include the SITE OF ACTION CODE in the third column; for Herbicides this is SITE OF ACTION • Include the type of pesticide {i.e., HERBICIDE) in the fourth column. Front Panel, upper right quadrant. All text should be black, bold face and all caps on a white background, except the mode of action code, which should be white, bold face and all caps on a black background; all text and columns should be surrounded by a black rectangle. [Applies to all products except those for residential consumer use.] Triclopyr GROUP HERBICIDE HERBICIDE RESISTANCE MANAGEMENT: Weed Resistance Management [Applies to all products except those for residential consumer use.] Include resistance management label language for herbicides from PRN 2017-1 and PRN 2017-2 diftDs://www.eDa.gov/Dest!cide-reg!stration/Dest!C!de-reeistratjon-not!ces-veart Directions for Use, prior to directions for specific crops under the heading "WEED RESISTANCE- MANAGEMENT" Updated Gloves Statement Update the gloves statements to be consistent with Chapter 10 of the Label Review Manual. In particular, remove reference to specific categories in EPA's chemical-resistance category selection chart and list the appropriate chemical-resistant glove types to use. In the Personal Protective Equipment (PPE) within the Precautionary Statements and 43 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov Description l.ahcl Language for Triclopj r Products Placement on l.ahcl Agricultural Use Requirements, if applicable Respirator Language for aerial applications via helicopter to forestry use sites "In addition, for mixers and loaders supporting aerial applications via helicopter to forestry sites must" [Note to registrant: If your end-use product only requires protection from particulates only (low volatility), use the following language:] "Wear a minimum of a NIOSH-approved particulate filtering facepiece respirator with any N*, R or P filter; OR a NIOSH-approved elastomeric particulate respirator with any N*, R or P filter; OR a NIOSH- approved powered air purifying respirator with HE filters." *Drop the "N" option if there is oil in the product's formulation and/or the product is labeled for mixing with oil-containing products. [Note to registrant: For respiratory protection from organic vapor and particulates (or aerosols), use the following language:] "Wear a minimum of a NIOSH-approved elastomeric half mask respirator with organic vapor (OV) cartridges and combination N*, R, or P filters; OR a NIOSH-approved gas mask with OV canisters; OR a NIOSH-approved powered air purifying respirator with OV cartridges and combination HE filters." [Note to registrant: For products reauirins protection for oreanic vaoor onlv. use the following language:] "Wear a minimum of a NIOSH-approved elastomeric half mask respirator with organic vapor (OV) cartridges; OR a NIOSH-approved full face respirator with OV cartridges; OR a gas mask with OV canisters; OR a powered air purifying respirator with OV cartridges." *Drop the "N" option if there is oil in the product's formulation and/or the product is labeled for mixing with oil-containing products. Personal Protective Equipment (PPE) within the Precautionary Statements Non-target Organism Advisory "NON-TARGET ORGANISM ADVISORY: This product is toxic to plants and may adversely impact the forage and habitat of non-target organisms, including pollinators, in areas adjacent to the treated site. Protect the forage and habitat of non-target organisms by following label directions intended to minimize spray drift." Environmental Hazards Fish and Aquatic Invertebrate Statement for Triclopyr BEE Products "This product is toxic to fish and aquatic invertebrates. Drift and runoff may be hazardous to aquatic organisms in water adjacent to treated areas." Environmental Hazards 44 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov Description l.ahcl Language for Iriclopv r Products Placcmcnl on l.ahcl Groundwater Advisory "GROUNDWATER ADVISORY This chemical has properties and characteristics associated with chemicals detected in groundwater. This chemical may leach into groundwater if used in areas where soils are permeable, particularly where the water table is shallow." Environmental Hazards Surface Water Advisory for products with Non- Agricultural uses "This product may impact surface water quality due to runoff of rain water. This is especially true for poorly draining soils and soils with shallow ground water. This product is classified as having high potential for reaching surface water via runoff for several weeks after application." Environmental Hazards Surface Water Advisory for Products with Agricultural Uses "This product may impact surface water quality due to runoff of rain water. This is especially true for poorly draining soils and soils with shallow groundwater. This product is classified as having high potential for reaching surface water via runoff for several weeks after application. A level, well-maintained vegetative buffer strip between areas to which this product is applied and surface water features such as ponds, streams, and springs will reduce the potential loading of triclopyr from runoff water and sediment. Runoff of this product will be reduced by avoiding applications when rainfall or irrigation is expected to occur within 48 hours." Environmental Hazards Aquatic Weed Control Statement for Products used to Control Aquatic Vegetation "Waters treated with this product may be hazardous to aquatic organisms. Treatment of aquatic weeds can result in oxygen loss from decomposition of dead biomass. This oxygen loss can cause fish and invertebrate suffocation. To minimize this hazard, do not treat more than '/? of the water body in a single operation and wait at least 14 days between treatments to avoid depletion of oxygen due to decaying vegetation (excluding water infrastructure and constructed conveyances such as drainage and irrigation canals, ditches and pipelines or reservoirs for drinking water). Begin treatment along the shore and proceed outward in bands to allow fish to move into untreated areas. Consult with the state or local Agency with primary responsibility for regulating pesticides before applying to public waters to determine if a permit is required." Environmental Hazards Clarification of application rates and minimum retreatment intervals for non-crop areas, forestry, turf, ornamental, rangeland/ pasture, and aquatic vegetation management Labels must clearly state the maximum single application rate, the maximum yearly rate, and the minimum retreatment interval for all uses. Maximum application parameters are as noted below: Directions for Use Use site Maximum single application rate (lb ae/A) Maximum yearly application rate (lb ae/A) Minimum retreati interval (days) Pasture and rangeland 2 2 28 Spot treatment on non- cropland, rights of way, and forestry sites that intersect grazed areas (e.g., public easements) 8 8 28 Forestry 6 6 28 45 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov Description l.ahcl Language for Triclopj r Products Placcmcnl on l.ahcl Non-crop areas (including rights of ways, fencerows, and similar areas) for triclopyr TEA 9 9 28 Non-crop areas (including rights of ways, fencerows, and similar areas) for triclopyr BEE 8 8 28 Turf and ornamentals 1 4 28 Foliar applications to floating/emerged weeds in aquatic water bodies 6 6 14 Rate clarification for grazable areas intersecting with treated non-cropland, rights of way, and forestry sites Replace label language specifying rates for grazable areas intersecting with treated non-cropland, rights of way, and forestry sites with: "The maximum application rate for spot treatments on non-cropland, rights-of-way, and forestry sites that intersect grazed areas is 8 lb ae/A/year." Directions for Use Rate clarification for in- water application for aquatic weed control use (acre-foot units, water depth, and surface area information) The rates for aquatic weed control should include the appropriate units associated with these applications (lb ae of triclopyr/acre-foot) and also reflect the appropriate depth and area of the water body to help add clarity to the label. A table can be included which provides information on rates expressed via depth and surface area. Directions for Use Compost restriction Clean out period for livestock "This product is persistent and may be present in treated plant materials for over 30 days after application. Do not sell or transport treated plant materials or manure from animals that have grazed on treated plant materials off-site for compost distribution or for use as animal bedding/feed for 30 days after application." Directions for use For products with pasture and turf use sites "Animals that have been fed triclopyr treated forage must be fed forage free of triclopyr for at least 3 days before movement to an area where manure may be collected, or sensitive crops are grown." Additional Required Labelling Action Applies to all products delivered via liquid spray applications Remove information about volumetric mean diameter from all labels where such information currently appears. Directions for Use 46 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov Description l.ahcl Language for Triclopj r Products Placemen! on l.ahcl Spray Drift Management Application Restrictions for all products delivered via liquid spray and allow aerial application "MANDATORY SPRAY DRIFT MANAGEMENT Aerial ADDlications: • Do not release spray at a height greater than 10 ft above the ground or vegetative canopy, unless a greater application height is necessary for pilot safety. • Applicators are required to select the nozzle and pressure that deliver a medium or coarser droplet size (ASABE S641). • If the windspeed is 10 miles per hour or less, applicators must use Vi swath displacement upwind at the downwind edge of the field. When the windspeed is between 11-15 miles per hour, applicators must use swath displacement upwind at the downwind edge of the field. • Do not apply when wind speeds exceed 15 mph at the application site. If the windspeed is greater than 10 mph, the boom length must be 65% or less of the wingspan for fixed wing aircraft and 75% or less of the rotor diameter for helicopters. Otherwise, the boom length must be 75% or less of the wingspan for fixed-wing aircraft and 90% or less of the rotor diameter for helicopters • Do not apply during temperature inversions." Directions for Use, in a box titled "Mandatory Spray Drift Management" under the heading "Aerial Applications" Placement for these statements should be in general directions for use, before use-specific directions. Spray Drift Management Application Restrictions for products that are applied as liquids and allow ground boom applications "MANDATORY SPRAY DRIFT MANAGEMENT Ground Boom ADDlications: • User must only apply with the release height recommended by the manufacturer, but no more than 4 feet above the ground or crop canopy. • Applicators are required to select the nozzle and pressure that deliver a medium or coarser droplet size (ASABE S572). • Do not apply when wind speeds exceed 15 mph at the application site. • Do not apply during temperature inversions." Directions for Use, in a box titled "Mandatory Spray Drift Management" under the heading "Ground Boom Applications" Spray Drift Management Application Restrictions for products that are applied as liquids and allow boom- less ground sprayer applications (this includes application to roadsides and rights of ways) "MANDATORY SPRAY DRIFT MANAGEMENT Boom-less Ground SDraver ADDlications: • Do not apply when wind speeds exceed 15 mph at the application site. • Do not apply during temperature inversions." Directions for Use, in a box titled "Mandatory Spray Drift Management" under the heading "Boom-less Applications" Advisory Spray Drift Management Language "SPRAY DRIFT ADVISORIES THE APPLICATOR IS RESPONSIBLE FOR AVOIDING OFF-SITE SPRAY DRIFT. Directions for Use, just below the 47 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov Description l.ahel Language for Triclopt r Products Placemen! on l.ahel for all products delivered via liquid spray application BE AWARE OF NEARBY NON-TARGET SITES AND ENVIRONMENTAL CONDITIONS. IMPORTANCE OF DROPLET SIZE An effective way to reduce spray drift is to apply large droplets. Use the largest droplets that provide target pest control. While applying larger droplets will reduce spray drift, the potential for drift will be greater if applications are made improperly or under unfavorable environmental conditions. Controlling Droplet Size - Ground Boom (note to registrants: remove if ground boom is prohibited on product labels) • Volume - Increasing the spray volume so that larger droplets are produced will reduce spray drift. Use the highest practical spray volume for the application. If a greater spray volume is needed, consider using a nozzle with a higher flow rate. • Pressure - Use the lowest spray pressure recommended for the nozzle to produce the target spray volume and droplet size. • Spray Nozzle - Use a spray nozzle that is designed for the intended application. Consider using nozzles designed to reduce drift. Controlling Droplet Size - Aircraft (note to registrants: remove if aerial application is prohibited on product labels) • Adjust Nozzles - Follow nozzle manufacturers' recommendations for setting up nozzles. Generally, to reduce fine droplets, nozzles should be oriented parallel with the airflow in flight. BOOM HEIGHT - Ground Boom (note to registrants: remove if ground boom is prohibited on product labels) For ground equipment, the boom should remain level with the crop and have minimal bounce. RELEASE HEIGHT - Aircraft (note to registrants: remove if aerial application is prohibited on product labels) Higher release heights increase the potential for spray drift. SHIELDED SPRAYERS Shielding the boom or individual nozzles can reduce spray drift. Consider using shielded sprayers. Verify that the shields are not interfering with the uniform deposition of the spray on the target area. TEMPERATURE AND HUMIDITY When making applications in hot and dry conditions, use larger droplets to reduce effects of evaporation. TEMPERATURE INVERSIONS Spray Drift box, under the heading "Spray Drift Advisories" 48 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov Description l.ahcl Language lor Iriclopv r Products Placement on l.ahcl Drift potential is high during a temperature inversion. Temperature inversions are characterized by increasing temperature with altitude and are common on nights with limited cloud cover and light to no wind. The presence of an inversion can be indicated by ground fog or by the movement of smoke from a ground source or an aircraft smoke generator. Smoke that layers and moves laterally in a concentrated cloud (under low wind conditions) indicates an inversion, while smoke that moves upward and rapidly dissipates indicates good vertical air mixing. Avoid applications during temperature inversions. WIND Drift potential generally increases with wind speed. AVOID APPLICATIONS DURING GUSTY WIND CONDITIONS. Applicators need to be familiar with local wind patterns and terrain that could affect spray drift." Advisory Spray Drift Management Language for products that are applied as liquids and allow boom- less ground sprayer applications "SPRAY DRIFT ADVISORIES Boomless Ground ADDlications: Setting nozzles at the lowest effective height will help to reduce the potential for spray drift." Directions for Use, just below the Spray Drift box, under the heading "Spray Drift Advisories" Advisory Spray Drift Management Language for all products that allow liquid applications with handheld technologies "SPRAY DRIFT ADVISORIES Handheld Technology ADDlications: • Take precautions to minimize spray drift." Directions for Use, just below the Spray Drift box, under the heading "Spray Drift Advisories" 49 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov Appendix D: Endangered Species Assessment In 2013, the EPA, along with the Fish and Wildlife Service (FWS), the National Marine Fisheries Service (NMFS), and the United States Department of Agriculture (USDA) released a summary of their joint Interim Approaches for assessing risks to endangered and threatened (listed) species from pesticides. These Interim Approaches were developed jointly by the agencies in response to the National Academy of Sciences' (NAS) recommendations that discussed specific scientific and technical issues related to the development of pesticide risk assessments conducted on federally threatened and endangered species. Since that time, EPA has conducted biological evaluations (BEs) on three pilot chemicals representing the first nationwide pesticide consultations (final pilot BEs for chlorpyrifos, malathion, and diazinon were completed in January 2017). These initial pilot consultations were envisioned to be the start of an iterative process. The agencies are continuing to work to improve the consultation process. For example, after receiving input from the Services and USDA on proposed revisions to the pilot interim method and after consideration of public comments received, EPA released an updated Revised Method for conducting national level BEs in March 2020.24 Also, a provision in the December 2018 Farm Bill included the establishment of a FIFRA Interagency Working Group to provide recommendations for improving the consultation process required under section 7 of the Endangered Species Act for pesticide registration and Registration Review and to increase opportunities for stakeholder input. This group includes representation from EPA, NMFS, FWS, USDA, and the Council on Environmental Quality (CEQ). Given this new law and that the first nationwide pesticide consultations were envisioned as pilots, the agencies are continuing to work collaboratively as consistent with the congressional intent of this new statutory provision. EPA has been tasked with a lead role in this group, and EPA hosted the first Principals Working Group meeting on June 6, 2019. Given that the agencies are continuing to develop and work toward implementation of approaches to assess the potential risks of pesticides to listed species and their designated critical habitat, the ecological risk assessment supporting this ID for triclopyr does not contain a complete ESA analysis that includes effects determinations for specific listed species or designated critical habitat. Although the EPA has not yet completed effects determinations for specific species or habitats, for this ID, the EPA's evaluation assumed, for all taxa of non-target wildlife and plants, that listed species and designated critical habitats may be present in the vicinity of the application of triclopyr. This will allow the EPA to focus its future evaluations on the types of species where the potential for effects exists once the scientific methods being developed by the agencies have been fully vetted. Once that occurs, these methods will be applied to subsequent analyses for triclopyr as part of completing this registration review. 24 https://www.epa.gov/endangered-species/revised-mefhod-national-level-listed-species-biological-evalnations- eonventional 50 ------- Docket Number EPA-HQ-OPP-2014-0576 www.regulations.gov Appendix E: Endocrine Disruptor Screening Program As required by FIFRA and FFDCA, the EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute, sub- chronic and chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influence, including effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, the EPA evaluates acute tests and chronic studies that assess growth, developmental and reproductive effects in different taxonomic groups. As part of its most recent registration decision for triclopyr, the EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA § 408(p), triclopyr is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP). The EPA has developed the EDSP to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a "naturally occurring estrogen, or other such endocrine effects as the Administrator may designate." The EDSP employs a two-tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where the EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any adverse endocrine-related effects caused by the substance, and establish a dose-response relationship between the dose and the E, A, or T effect. Under FFDCA § 408(p), the Agency must screen all pesticide chemicals. Between October 2009 and February 2010, the EPA issued test orders/data call-ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. The Agency has reviewed all of the assay data received for the List 1 chemicals and the conclusions of those reviews are available in the chemical-specific public dockets. A second list of chemicals identified for EDSP screening was published on June 14, 2013,25 and includes some pesticides scheduled for Registration Review and chemicals found in water. Neither of these lists should be construed as a list of known or likely endocrine disruptors. Triclopyr is not on either list. For further information on the status of the EDSP, the policies and procedures, the lists of chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit the EPA website.26 In this ID, the EPA is making no human health or environmental safety findings associated with the EDSP screening of triclopyr. Before completing this registration review, the Agency will make an EDSP FFDCA § 408(p) determination. 25 See http://www.reaulations.gov/#!documentDetail:D=EPA-HO-OPPT-2009-0477-0Q74 for the final second list of chemicals. 26 https://www.epa.gov/endocrine-dismption 51 ------- |